ABSTRACT
Objective: To investigate the effects of cervical cold knife conization (CKC) on preterm delivery, other pregnancy complications and neonatal outcomes, and explore the relationship between preterm delivery risk and the depth and volume of conization. Methods: The clinical data and pregnancy outcomes of 272 women who underwent CKC in Peking Union Medical College Hospital from January 2002 to March 2018 (conization group) and 1 647 pregnant women who gave birth in Peking Union Medical College Hospital during January to December 2019 (control group) were collected. The preterm delivery, premature rupture of membranes, other pregnancy complications and neonatal outcomes of the two groups were compared, and the relationship between the depth and volume of conization and the risk of preterm delivery in postoperative singleton pregnancy was analyzed. Results: (1) There were no significant differences between the two groups in delivery age, parity, proportion of singleton pregnancy, proportion of assisted reproductive technology (all P>0.05). (2) The rate of preterm delivery in the conization group was significantly higher than that in the control group [14.8% (39/264) vs 5.7% (91/1 589); χ2=28.397, P<0.001]. There were still significant differences in preterm delivery rates between the two groups at <34 weeks and 34-37 weeks (all P<0.01). There was no significant difference in the incidence of premature rupture of membrane between the two groups [23.5% (62/264) vs 23.4% (372/1 589); χ2=0.001, P=0.979], but the incidence of preterm premature rupture of membrane in the conization group was significantly higher than that in the control group [11.4% (30/264) vs 2.2% (35/1 589); χ2=56.132, P<0.001]. (3) The rate of cesarean section in the conization group was higher than that in the control group [59.6% (162/272) vs 38.8% (639/1 647); χ2=41.377, P<0.001]. The birth weight of preterm infants in the conization group was significantly higher than that in the control group [(2 409±680) vs (2 150±684) g; t=2.184, P=0.030]. However, there were no statistically significant differences in the incidence of gestational diabetes mellitus, hypertensive disorders in pregnancy, the birth weight of full-term infants, incidence of small for gestational age infant and neonatal intensive care unit admission rate between the two groups (all P>0.05). (4) The preterm delivery rates of coning depth >15 mm, cone size ≥2 cm3 and cone size <2 cm3 were higher than that in the control group (all P<0.05). When the coning depth ≤15 mm, the preterm delivery rate in the conization group was higher than that in the control group, but there was no significant difference (P=0.620). The rate of preterm delivery of pregnant women with coning depth >15 mm was significantly higher than those with coning depth ≤15 mm (RR=3.084, 95%CI: 1.474-6.453; P=0.001). There was no significant difference in the preterm delivery rate between pregnant women with cone size >2 cm3 and those with cone size ≥2 cm3 (RR=1.700, 95%CI: 0.935-3.092; P=0.077). Conclusion: The risk of preterm delivery and preterm premature rupture of membranes in subsequent pregnancies are increased after cervical CKC, and the risk of preterm delivery is positively correlated with the depth of cervical coning.
Subject(s)
Cervix Uteri , Conization , Fetal Membranes, Premature Rupture , Pregnancy Outcome , Premature Birth , Humans , Female , Pregnancy , Conization/adverse effects , Conization/methods , Premature Birth/epidemiology , Adult , Fetal Membranes, Premature Rupture/epidemiology , Pregnancy Complications/epidemiology , Retrospective Studies , Infant, Newborn , Uterine Cervical Neoplasms/surgery , Uterine Cervical Neoplasms/epidemiology , Uterine Cervical Neoplasms/pathology , Uterine Cervical Dysplasia/surgery , Uterine Cervical Dysplasia/epidemiologyABSTRACT
BACKGROUND: Foetal reduction, which involves selectively terminating one or more foetuses in a multiple gestation pregnancy, has become more common. This systematic review and meta-analysis aims to assess and compare pregnancy outcomes of foetal reduction from twin to singleton gestation to ongoing twin gestations. METHODS: A comprehensive search of electronic databases (MEDLINE, EMbase, Cochrane Library, CINAHL and PsycINFO) was done for studies published until 15 April 2023. The outcomes analysed included gestational diabetes mellitus (DM), hypertension, caesarean delivery, foetal loss, perinatal death, preterm birth (PTB), intrauterine growth restriction (IUGR), preterm prelabour rupture of membranes (PPROM) and birth weight. RESULTS: A total of 13 studies comprising 1241 cases of twin to singleton foetal reduction gestation were compared to 20,693 ongoing twin gestations. Our findings indicate that foetal reduction was associated with a significantly lower risk of developing maternal gestational DM (odds ratio [OR] = 0.40, 95% confidence interval [CI] 0.27-0.59) and hypertension (OR = 0.36, 95% CI 0.23-0.57) compared to the control group. Incidence rate of caesarean delivery (OR = 0.65, 95% CI 0.53-0.81) after foetal reduction was significantly lower compared to ongoing twin gestations. There was a 63% lower chance of PTB before 37 weeks of pregnancy. However, there was no significant association between foetal reduction and outcomes such as foetal loss, perinatal death, IUGR and PPROM. CONCLUSIONS: Our findings suggest that foetal twin to singleton reduction entails potential benefits as compared to ongoing twin gestations. Further well planned studies are needed to explore underlying mechanisms to understanding of the outcomes associated with foetal reduction procedures and inform clinical decision-making for pregnant individuals and healthcare providers alike.
Foetal reduction, a procedure where one or more foetuses in a twin pregnancy are selectively terminated, has become more common. This study reviewed existing research to compare the outcomes of foetal reduction to singleton pregnancies with those of ongoing twin pregnancies. The study found that mothers who underwent foetal reduction had a lower risk of developing gestational diabetes and hypertension, and they were less likely to have a caesarean delivery. There was also a reduced chance of preterm birth before 37 weeks. However, foetal reduction did not appear to significantly impact outcomes like foetal loss, perinatal death, intrauterine growth restriction or preterm pre-labour rupture of membranes. It is important to note that there is some variation in the results among different studies, and more research is needed to fully understand these findings.
Subject(s)
Pregnancy Outcome , Pregnancy Reduction, Multifetal , Pregnancy, Twin , Humans , Pregnancy , Female , Pregnancy Outcome/epidemiology , Pregnancy Reduction, Multifetal/methods , Pregnancy Reduction, Multifetal/statistics & numerical data , Premature Birth/prevention & control , Premature Birth/epidemiology , Cesarean Section/statistics & numerical data , Infant, Newborn , Fetal Growth Retardation , Fetal Membranes, Premature Rupture/epidemiology , Diabetes, Gestational/epidemiologyABSTRACT
BACKGROUND: What kinds of fetal adverse outcomes beyond stillbirth directly correlate to the severity of intrahepatic cholestasis during pregnancy (ICP) remained tangled. Herein, we conducted a retrospective cohort study and a dose-response meta-analysis to speculate the association between the severity of ICP and its adverse outcomes. METHODS: We retrospectively collected a cohort of ICP patients from electronic records from Guangzhou Women and Children's Medical Center between Jan 1st, 2018, and Dec 31st, 2022. Also, we searched PubMed, Cochrane, Embase, Scopus, and Web of Science to extract prior studies for meta-analysis. The Kruskal-Wallis test, a one-way or two-way variants analysis (ANOVA), and multi-variant regression are utilized for cohort study. One stage model, restricted cubic spline analysis, and fixed-effect model are applied for dose-response meta-analysis. The data analysis was performed using the R programme. RESULTS: Our cohort included 1,289 pregnant individuals, including 385 mild ICP cases, 601 low moderate ICP cases, 282 high moderate ICP cases, and 21 severe ICP cases. The high moderate bile acid levels were correlated to preterm birth [RR = 2.14, 95%CI 1.27 to 3.62), P < 0.01], and preterm premature rupture of membranes [RR = 0.34, 95%CI 0.19 to 0.62), P < 0.01]. We added our cases to cases reported by other studies included in the meta-analysis. There were 15,826 patients included in dose-response meta-analysis. The severity of ICP was associated with increased risks of stillbirth, spontaneous preterm birth, iatrogenic preterm birth, preterm birth, admission to neonatal intensive care unit, and meconium-stained fluid (P < 0.05). CONCLUSIONS: Our study shows the correlation between the severity of ICP and the ascending risks of stillbirth, preterm birth, and meconium-stained fluid, providing new threshold TBA levels. PROSPERO REGISTRATION NUMBER: CRD42023472634.
Subject(s)
Cholestasis, Intrahepatic , Pregnancy Complications , Premature Birth , Severity of Illness Index , Stillbirth , Humans , Cholestasis, Intrahepatic/epidemiology , Cholestasis, Intrahepatic/complications , Female , Pregnancy , Pregnancy Complications/epidemiology , Retrospective Studies , Stillbirth/epidemiology , Adult , Premature Birth/epidemiology , Infant, Newborn , China/epidemiology , Pregnancy Outcome/epidemiology , Fetal Membranes, Premature Rupture/epidemiology , Risk FactorsABSTRACT
In this investigation, we explored the correlation between first-trimester biochemical markers and the incidence of preterm birth (PTB), irrespective of the cause, spontaneous preterm birth (sPTB), and preterm premature rupture of membranes (pPROM) within a cohort comprising 1164 patients. It was discovered that diminished levels of Pregnancy-Associated Plasma Protein-A (PAPP-A) between 11 and 13 + 6 weeks of gestation significantly contributed to the risk of preterm deliveries both before 35 and 37 weeks, as well as to pPROM instances. Furthermore, women experiencing sPTB before the 37th week of gestation also exhibited lower concentrations of PAPP-A. Moreover, reduced first-trimester concentrations of free beta-human chorionic gonadotropin (fb-HCG) were identified as a risk factor for deliveries preceding 37 weeks, pPROM, and sPTB before 35 weeks of gestation. Despite these correlations, the area under the curve for these biochemical markers did not surpass 0.7, indicating their limited diagnostic potential. The most significant discriminatory capability was noted for PAPP-A levels, with a threshold of < 0.71 multiples of the median (MoM) predicting PTB before 37 weeks, yielding an odds ratio of 3.11 (95% Confidence Interval [CI] 1.97-4.92). For sPTB, the greatest discriminatory potential was observed for PAPP-A < 0.688, providing an OR of 2.66 (95% CI 1.51-4.66). The cut-off points corresponded to accuracies of 76.05% and 79.1%, respectively. In regression analyses, the combined predictive models exhibited low explanatory power with R2 values of 9.2% for PTB and 7.7% for sPTB below 35 weeks of gestation. In conclusion, while certain biochemical markers demonstrated associations with outcomes of preterm birth, their individual and collective predictive efficacies for foreseeing such events were found to be suboptimal.
Subject(s)
Biomarkers , Chorionic Gonadotropin, beta Subunit, Human , Pregnancy Trimester, First , Pregnancy-Associated Plasma Protein-A , Premature Birth , Humans , Pregnancy , Female , Pregnancy-Associated Plasma Protein-A/metabolism , Pregnancy-Associated Plasma Protein-A/analysis , Pregnancy Trimester, First/blood , Premature Birth/blood , Premature Birth/epidemiology , Biomarkers/blood , Chorionic Gonadotropin, beta Subunit, Human/blood , Adult , Incidence , Fetal Membranes, Premature Rupture/blood , Fetal Membranes, Premature Rupture/epidemiology , Fetal Membranes, Premature Rupture/diagnosis , Risk FactorsABSTRACT
OBJECTIVE: This study aimed to examine prospective associations of different intensity levels and types of physical activity (PA) in early pregnancy with premature rupture of membranes (PROM) among Chinese pregnant women. METHODS: A total of 6284 pregnant women were included from the Tongji-Shuangliu Birth Cohort. Household/caregiving, occupational, sports/exercise and transportation activities during early pregnancy were investigated by the pregnancy physical activity questionnaire (PPAQ), and the diagnosis of PROM was ascertained during the whole pregnancy. Multivariate logistic regression models were used to estimate the odds ratios (ORs) and 95% confidence interval (CI) for the associations between PA and PROM. RESULTS: Among the 6284 pregnant women, 1246 were identified to have PROM (19.8%). Women undertaking the highest level (3 third tertile) of PA during pregnancy appeared to have a lower risk of PROM [OR = 0.68, 95%CI 0.58-0.80) when compared to those at the lowest tertile of PA. Similarly, women with increased levels of light intensity activity, moderate-vigorous intensive, household/caregiving activity and meeting exercise guidelines during pregnancy were associated with reduced risks of PROM (OR = 0.69, 95% CI 0.59-0.81, OR = 0.70, 95% CI 0.60-0.82, OR = 0.62, 95% CI 0.53-0.73 and OR = 0.82, 95% CI 0.70-0.97, respectively). CONCLUSIONS: High levels of PA of different intensities and PA of household/caregiving activities and meeting exercise guidelines during the first trimester were associated with a lower incidence of PROM. TRIAL REGISTRATION: The data of human participants in this study were conducted in accordance with the Helsinki Declaration. This study has been approved by the Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China ([2017] No. S225). All participants provided written informed consent prior to enrollment. A statement to confirm that all methods were carried out in accordance with relevant guidelines and regulations.
Subject(s)
Exercise , Fetal Membranes, Premature Rupture , Pregnancy Trimester, First , Humans , Female , Pregnancy , Adult , Fetal Membranes, Premature Rupture/epidemiology , China , Prospective Studies , Birth Cohort , Young Adult , Surveys and Questionnaires , Risk Factors , Cohort Studies , East Asian PeopleABSTRACT
OBJECTIVE: The objective of the meta-analysis was to determine the influence of uterine fibroids on adverse outcomes, with specific emphasis on multiple or large (≥ 5 cm in diameter) fibroids. MATERIALS AND METHODS: We searched PubMed, Embase, Web of Science, ClinicalTrials.gov, China National Knowledge Infrastructure (CNKI), and SinoMed databases for eligible studies that investigated the influence of uterine fibroids on adverse outcomes in pregnancy. The pooled risk ratio (RR) of the variables was estimated with fixed effect or random effect models. RESULTS: Twenty-four studies with 237 509 participants were included. The pooled results showed that fibroids elevated the risk of adverse outcomes, including preterm birth, cesarean delivery, placenta previa, miscarriage, preterm premature rupture of membranes (PPROM), placental abruption, postpartum hemorrhage (PPH), fetal distress, malposition, intrauterine fetal death, low birth weight, breech presentation, and preeclampsia. However, after adjusting for the potential factors, negative effects were only seen for preterm birth, cesarean delivery, placenta previa, placental abruption, PPH, intrauterine fetal death, breech presentation, and preeclampsia. Subgroup analysis showed an association between larger fibroids and significantly elevated risks of breech presentation, PPH, and placenta previa in comparison with small fibroids. Multiple fibroids did not increase the risk of breech presentation, placental abruption, cesarean delivery, PPH, placenta previa, PPROM, preterm birth, and intrauterine growth restriction. Meta-regression analyses indicated that maternal age only affected the relationship between uterine fibroids and preterm birth, and BMI influenced the relationship between uterine fibroids and intrauterine fetal death. Other potential confounding factors had no impact on malposition, fetal distress, PPROM, miscarriage, placenta previa, placental abruption, and PPH. CONCLUSION: The presence of uterine fibroids poses increased risks of adverse pregnancy and obstetric outcomes. Fibroid size influenced the risk of breech presentation, PPH, and placenta previa, while fibroid numbers had no impact on the risk of these outcomes.
Subject(s)
Leiomyoma , Pregnancy Outcome , Uterine Neoplasms , Female , Humans , Pregnancy , Abortion, Spontaneous/epidemiology , Abortion, Spontaneous/etiology , Abruptio Placentae/epidemiology , Abruptio Placentae/etiology , Breech Presentation/epidemiology , Cesarean Section/statistics & numerical data , Fetal Membranes, Premature Rupture/epidemiology , Fetal Membranes, Premature Rupture/etiology , Leiomyoma/epidemiology , Leiomyoma/complications , Placenta Previa/epidemiology , Postpartum Hemorrhage/epidemiology , Postpartum Hemorrhage/etiology , Pregnancy Complications, Neoplastic/epidemiology , Pregnancy Outcome/epidemiology , Premature Birth/epidemiology , Premature Birth/etiology , Risk Factors , Uterine Neoplasms/epidemiology , Uterine Neoplasms/complicationsABSTRACT
BACKGROUND Exposure to air pollution (AP) during pregnancy is associated with pre-labor rupture of membranes (PROM). However, there is limited research on this topic, and the sensitive exposure windows remain unclear. The present study assessed the association between AP exposure and the risk of PROM, as well as seeking to identify the sensitive time windows. MATERIAL AND METHODS This retrospective study analyzed 4276 pregnant women's data from Tongling Maternal and Child Health Hospital from 2020 to 2022. We obtained air pollution data, including particulate matter (PM) with an aerodynamic diameter of ≤2.5 µm (PM2â¤5), particulate matter with an aerodynamic diameter of ≤10 µm (PM10), nitrogen dioxide (NO2), and ozone (O3), from the Tongling Ecology and Environment Bureau. Demographic information was extracted from medical records. We employed a distributed lag model to identify the sensitive exposure windows of prenatal AP affecting the risk of PROM. We conducted a sensitivity analysis based on pre-pregnancy BMI. RESULTS We found a significant association between prenatal exposure to AP and increased PROM risk after adjusting for confounders, and the critical exposure windows of AP were the 6th to 7th months of pregnancy. In the underweight group, an increase of 10 µg/m³ in PM2â¤5 was associated with a risk of PROM, with an odds ratio (OR) of 1.48 (95% CI: 1.16, 1.89). Similarly, a 10 µg/m³ increase in PM10 was associated with a risk of PROM, with an OR of 1.45 (95% CI: 1.05, 1.77). CONCLUSIONS Prenatal exposure to AP, particularly during months 6-7 of pregnancy, is associated with an increased risk of PROM. This study extends and strengthens the evidence on the association between prenatal exposure to AP and the risk of PROM, specifically identifying the critical exposure windows.
Subject(s)
Air Pollutants , Air Pollution , Fetal Membranes, Premature Rupture , Maternal Exposure , Particulate Matter , Humans , Female , Pregnancy , China/epidemiology , Fetal Membranes, Premature Rupture/etiology , Fetal Membranes, Premature Rupture/epidemiology , Maternal Exposure/adverse effects , Air Pollution/adverse effects , Particulate Matter/adverse effects , Adult , Retrospective Studies , Air Pollutants/adverse effects , Air Pollutants/analysis , Air Pollutants/toxicity , Risk Factors , Ozone/adverse effects , Nitrogen Dioxide/analysis , Nitrogen Dioxide/adverse effectsABSTRACT
Indonesia has a significantly higher maternal mortality ratio (MMR) than other countries in Southeast Asia, and infection is one of the most common causes of maternal deaths, of which premature rupture of membranes (PROM) can be the consequence of the infections. In primary healthcare settings, midwives play an important role in identifying and managing PROM appropriately; however, studies on their knowledge, attitudes, and practices related to PROM are limited. The aim of this study was to determine the midwives' knowledge, attitude and healthcare practice on PROM in Indonesia. A cross-sectional study was conducted among midwives at primary healthcare facilities in Samosir and Toba Regency, North Sumatra, Indonesia, from July to November 2022. The knowledge, attitude and practice towards PROM were assessed. Results showed that 57.5% of midwives had poor knowledge and 35.1% had poor attitude levels. There were 4.9% of midwives referred the patients immediately to the hospital. Our data indicated that aged 31-40 or 41-50 years, having a lower than bachelor degree and having a higher monthly number of referred PROM patients were significantly associated with poor knowledge compared to younger, having a bachelor degree, and lower monthly referral patient number, respectively. Similarly, younger, having higher degree and a having lower monthly referral number of PROM cases were associated with higher chances of having a sufficient-good attitude towards PROM. This study highlights that a significant percentage of midwives had poor levels of knowledge and attitude, and age, educational level and monthly referral number of PROM cases were associated with the level of knowledge and attitude.
Subject(s)
Fetal Membranes, Premature Rupture , Health Knowledge, Attitudes, Practice , Midwifery , Humans , Indonesia/epidemiology , Cross-Sectional Studies , Female , Adult , Pregnancy , Fetal Membranes, Premature Rupture/epidemiology , Middle Aged , Surveys and QuestionnairesABSTRACT
PURPOSE: Evaluate maternal and neonatal outcomes in peripartum coronavirus disease 2019 (COVID-19) positive women. METHODS: A retrospective cohort study was conducted, comparing outcomes between women with and without peripartum COVID-19. All singleton deliveries from June 2020 to January 2022 were included. Univariate analysis was followed by multivariate analysis. RESULTS: Of 26,827 singleton deliveries, 563 women had peripartum COVID-19, associated with preterm deliveries both near-term and remote from term [adjusted odds ratio (aOR) 1.6 and 2.0, respectively, p = 0.007 and 0.003]. Women with peripartum COVID-19 had a significantly higher rate of disseminated intravascular coagulation (DIC) (aOR 23.0, p < 0.001). Conversely, peripartum COVID-19 peripartum COVID-19 was negatively associated with premature rupture of membranes and prolonged maternal length of stay (aOR 0.7 and 0.5, respectively, p = 0.006 and <0.001). In cesarean delivery (CDs), patients with COVID-19 had higher rate of urgent CDs (75.5 vs. 56.1%, p < 0.001), higher rate of regional anesthesia (74.5 vs. 64.9%, p = 0.049), and longer anesthesia duration (86.1 vs. 53.4 min, p < 0.001). CD rate due to non-reassuring fetal heart rate (NRFHR) was significantly higher in women with COVID-19 (29.6 vs. 17.4%, p = 0.002). Conversely, CDs rate due to history of previous single CD was significantly higher in patients without COVID-19 diagnosis (13.6 vs. 4.1%, p = 0.006). Concerning neonatal outcomes, an association has been observed between COVID-19 and low one-minute APGAR score <5, as well as neonatal COVID-19 infection (aOR 61.8 and 1.7 respectively, p < 0.001 and p = 0.037). CONCLUSIONS: Peripartum COVID-19 is associated with preterm deliveries, urgent CDs and DIC, potentially aligning with the infection's pathophysiology and coagulation alterations.
Subject(s)
COVID-19 , Cesarean Section , Disseminated Intravascular Coagulation , Peripartum Period , Pregnancy Complications, Infectious , Pregnancy Outcome , Humans , Female , Pregnancy , COVID-19/complications , COVID-19/epidemiology , Retrospective Studies , Adult , Pregnancy Complications, Infectious/epidemiology , Pregnancy Complications, Infectious/virology , Pregnancy Outcome/epidemiology , Infant, Newborn , Cesarean Section/statistics & numerical data , Disseminated Intravascular Coagulation/epidemiology , Disseminated Intravascular Coagulation/etiology , SARS-CoV-2 , Premature Birth/epidemiology , Fetal Membranes, Premature Rupture/epidemiology , Fetal Membranes, Premature Rupture/virology , Length of Stay/statistics & numerical dataABSTRACT
BACKGROUND: Pregnant patients with preterm prelabor rupture of membranes (PPROM) may experience prolonged hospitalization, which is an indication for pharmacologic venous thromboembolism (VTE) prophylaxis according to certain international guidelines. The proportion of patients who deliver unexpectedly and within a period during which pharmacologic prophylaxis would be expected to impact coagulation is unknown. OBJECTIVE: To estimate the proportion of patients with PPROM who would deliver within 12 hours of typical dosing of pharmacologic VTE prophylaxis if administered routinely for antepartum admissions >72 hours. STUDY DESIGN: This is a retrospective cohort study from a database including patients admitted for expectant management of PPROM January 2011 to September 2020. The outcome of the study was the proportion of patients who remained undelivered 72 hours after admission and experienced an unplanned delivery potentially within 12 hours of enoxaparin administration. We evaluated patients undelivered after 72 hours due to international recommendations to initiate VTE prophylaxis in hospitalized patients after 72 hours. Unplanned delivery was defined as onset of spontaneous labor or other indication for immediate delivery. Timing of delivery was analyzed based on usual timing of enoxaparin administration daily at approximately 8 am and the recommendation to withhold regional anesthesia until 12 hours after a prophylactic dose. RESULTS: 1381 deliveries were identified as PPROM out of the 49,322 deliveries in our database. 139 cases were included after the following exclusions: delivery >35 weeks (N=641), rupture of membranes >34 weeks (N=145), delivery <72 hours after admission (N=409), insufficient data (N=35), and duplicates (N=12). Sixty of the 139 (43%) had an unplanned delivery, while 33 of these (24% of total) occurred within 12 hours of enoxaparin administration. CONCLUSION: A quarter of patients admitted for PPROM had an unplanned delivery within 12 hours of typical enoxaparin dosing. This cohort may experience harm (ineligibility for regional anesthesia, risks of general anesthesia, increased risk of bleeding) if given routine pharmacologic VTE prophylaxis. Risk/benefit considerations should be discussed with patients in considering pharmacologic versus mechanical prophylaxis during prolonged hospitalization for PPROM.
Subject(s)
Anticoagulants , Enoxaparin , Fetal Membranes, Premature Rupture , Venous Thromboembolism , Humans , Female , Fetal Membranes, Premature Rupture/epidemiology , Fetal Membranes, Premature Rupture/prevention & control , Venous Thromboembolism/prevention & control , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology , Pregnancy , Retrospective Studies , Adult , Enoxaparin/administration & dosage , Anticoagulants/administration & dosage , Delivery, Obstetric/methods , Delivery, Obstetric/adverse effects , Delivery, Obstetric/statistics & numerical dataABSTRACT
BACKGROUND: Cervical cerclage is the only effective treatment for cervical insufficiency, effectively preventing late miscarriage and preterm birth. The effectiveness and safety of emergency cervical cerclage (ECC) as an emergency treatment when the cervix is already dilated or when there is protrusion of the fetal membranes into the vagina remain controversial, especially in pregnancies at 24-28 weeks when the fetus is viable. There is still no consensus on whether emergency cervical cerclage should be performed in such cases. PURPOSE: To investigate the effectiveness and safety of emergency cervical cerclage in singleton pregnant women at 24-28 weeks of gestation. METHODS: This study employed a single-center prospective cohort design, enrolling singleton pregnant women at 24-28 weeks of gestation with ultrasound or physical examination indicating cervical dilation or even membrane protrusion. Emergency cervical cerclage was compared with conservative treatment. The primary endpoints included a comprehensive assessment of perinatal pregnancy loss, significant neonatal morbidity, and adverse neonatal outcomes. Secondary endpoints included prolonged gestational age, preterm birth, neonatal hospitalization rate, premature rupture of membranes, and intrauterine infection/chorioamnionitis. RESULTS: From June 2021 to March 2023, a total of 133 pregnant women participated in this study, with 125 completing the trial, and were allocated to either the Emergency Cervical Cerclage (ECC) group (72 cases) or the conservative treatment group (53 cases) based on informed consent from the pregnant women. The rate of adverse neonatal outcomes was 8.33% in the ECC group and 26.42% in the conservative treatment (CT) group, with a statistically significant difference (P = 0.06). There were no significant differences between the two groups in terms of perinatal pregnancy loss and significant neonatal morbidity. The conservative treatment group had a mean prolonged gestational age of 63.0 (23.0, 79.5) days, while the ECC group had 84.0 (72.5, 89.0) days, with a statistically significant difference between the two groups (P < 0.001). Compared with CT group, the ECC group showed a significantly reduced incidence of preterm birth before 28 weeks, 32 weeks, and 34 weeks, with statistical significance (P = 0.046, 0.007, 0.001), as well as a significantly decreased neonatal hospitalization rate (P = 0.013, 0.031). Additionally, ECC treatment did not increase the risk of preterm premature rupture of membranes or intrauterine infection/chorioamnionitis, with no statistically significant differences (P = 0.406, 0.397). CONCLUSION: In singleton pregnant women with cervical insufficiency at 24-28 weeks of gestation, emergency cervical cerclage can reduce adverse neonatal pregnancy outcomes, effectively prolong gestational age, decrease preterm births before 28 weeks, 32 weeks, and 34 weeks, lower neonatal hospitalization rates, and does not increase the risk of preterm premature rupture of membranes or intrauterine infection/chorioamnionitis.
Subject(s)
Cerclage, Cervical , Premature Birth , Uterine Cervical Incompetence , Humans , Female , Pregnancy , Adult , Prospective Studies , Premature Birth/prevention & control , Premature Birth/epidemiology , Uterine Cervical Incompetence/surgery , Gestational Age , Pregnancy Outcome , Infant, Newborn , Pregnancy Trimester, Second , Fetal Membranes, Premature Rupture/epidemiology , Emergencies , Abortion, Spontaneous/prevention & control , Abortion, Spontaneous/epidemiology , Emergency Treatment/statistics & numerical dataABSTRACT
OBJECTIVE: Counseling of pregnancies complicated by pre- and periviable premature rupture of membranes to reach shared decision-making is challenging, and the current limited evidence hampers the robustness of the information provided. This study aimed to elucidate the rate of obstetrical and neonatal outcomes after expectant management for premature rupture of membranes occurring before or at the limit of viability. DATA SOURCES: Medline, Embase, CINAHL, and Web of Science databases were searched electronically up to September 2023. STUDY ELIGIBILITY CRITERIA: Our study included both prospective and retrospective studies of singleton pregnancies with premature rupture of membranes before and at the limit of viability (ie, occurring between 14 0/7 and 24 6/7 weeks of gestation). METHODS: Quality assessment of the included studies was performed using the Newcastle-Ottawa Scale for cohort studies. Moreover, our study used meta-analyses of proportions to combine data and reported pooled proportions. Given the clinical heterogeneity, a random-effects model was used to compute the pooled data analyses. This study was registered with the International Prospective Register of Systematic Reviews database (registration number: CRD42022368029). RESULTS: The pooled proportion of termination of pregnancy was 32.3%. After the exclusion of cases of termination of pregnancy, the rate of spontaneous miscarriage or fetal demise was 20.1%, whereas the rate of live birth was 65.9%. The mean gestational age at delivery among the live-born cases was 27.3 weeks, and the mean latency between premature rupture of membranes and delivery was 39.4 days. The pooled proportion of cesarean deliveries was 47.9% of the live-born cases. Oligohydramnios occurred in 47.1% of cases. Chorioamnionitis occurred in 33.4% of cases, endometritis in 7.0%, placental abruption in 9.2%, and postpartum hemorrhage in 5.3%. Hysterectomy was necessary in 1.2% of cases. Maternal sepsis occurred in 1.5% of cases, whereas no maternal death was reported in the included studies. When focusing on neonatal outcomes, the mean birthweight was 1022.8 g in live-born cases. The neonatal intensive care unit admission rate was 86.3%, respiratory distress syndrome was diagnosed in 66.5% of cases, pulmonary hypoplasia or dysplasia was diagnosed in 24.0% of cases, and persistent pulmonary hypertension was diagnosed in 40.9% of cases. Of the surviving neonates, the other neonatal complications included necrotizing enterocolitis in 11.1%, retinopathy of prematurity in 27.1%, and intraventricular hemorrhage in 17.5%. Neonatal sepsis occurred in 30.2% of cases, and the overall neonatal mortality was 23.9%. The long-term follow-up at 2 to 4 years was normal in 74.1% of the available cases. CONCLUSION: Premature rupture of membranes before or at the limit of viability was associated with a great burden of both obstetrical and neonatal complications, with an impaired long-term follow-up at 2 to 4 years in almost 30% of cases, representing a clinical challenge for both counseling and management. Our data are useful when initially approaching such patients to offer the most comprehensive possible scenario on short- and long-term outcomes of this condition and to help parents in shared decision-making. El resumen está disponible en Español al final del artículo.
Subject(s)
Fetal Membranes, Premature Rupture , Fetal Viability , Humans , Fetal Membranes, Premature Rupture/epidemiology , Pregnancy , Female , Fetal Viability/physiology , Infant, Newborn , Pregnancy Outcome/epidemiology , Gestational Age , Cesarean Section/statistics & numerical data , Cesarean Section/methods , Watchful Waiting/methods , Watchful Waiting/statistics & numerical data , Abortion, Induced/statistics & numerical data , Abortion, Induced/methodsABSTRACT
Objective: To determine the various causes and factors leading to preterm birth in women presenting at tertiary care hospitals. METHODS: The cross-sectional, prospective study was conducted from June 19, 2021, to January 19, 2022, at the Central Park Teaching Hospital, Lahore, Pakistan, in collaboration with other tertiary care teaching hospitals in Lahore, and comprised pregnant women aged 15-45 years with preterm birth. Demographic and obstetric data was collected. Depending on the factors contributing to preterm birth, the subjects were categorised as spontaneous labour group A, preterm prelabour rupture of membrane group B, and iatrogenic preterm birth group C. Data was analysed using SPSS 25. RESULTS: Of the 1,300 recorded births, 200(15.38%) were preterm. Group A had 86(43%) women with mean age 28.55±4.68 years, group B had 43(21,5%) women with mean age 27.14±3.25 years, and group C had 71(35.5%) women with mean age 28.28±3.74 years (p>0.05). There was significant difference among the groups with respect to body mass index (p=0.001) and parity (p=0.021). Vaginal and urinary tract infections were significantly higher in group A compared to the other groups (p<0.05). In group C, pre-eclampsia was the main reason for preterm birth 45(63.38%). Conclusion: Medically indicated preterm birth rate was found to be high, and pre-eclampsia was noted as the main cause in iatrogenic preterm birth.
Subject(s)
Fetal Membranes, Premature Rupture , Pre-Eclampsia , Premature Birth , Pregnancy , Humans , Female , Infant, Newborn , Young Adult , Adult , Male , Premature Birth/epidemiology , Prospective Studies , Tertiary Care Centers , Cross-Sectional Studies , Fetal Membranes, Premature Rupture/epidemiology , Fetal Membranes, Premature Rupture/etiology , Risk Factors , Pre-Eclampsia/epidemiology , Iatrogenic DiseaseABSTRACT
OBJECTIVE: To identify risk factors for premature rupture of membranes (PROM) in pregnant women. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Web of Science, PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, Wanfang Database, Chinese Scientific Journal Database (VIP) and China Biology Medicine Disc were searched from inception to October 2022. ELIGIBILITY CRITERIA: Cross-sectional, case-control and cohort studies published in English or Chinese that reported the risk factors for PROM were eligible for inclusion. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted the data and evaluated the risk of bias using the Newcastle-Ottawa Scale and American Agency for Healthcare Research and Quality tools. Analyses were performed using RevMan 5.4 software, and heterogeneity was assessed using χ2 tests and I2 statistics. The sensitivity analyses included a methodological transition between fixed-effect and random-effect models and the systematic stepwise exclusion of studies. RESULTS: A total of 21 studies involving 18 174 participants with 18 risk factors were included. The significant risk factors were low Body Mass Index (BMI) (OR 2.18, 95% CI 1.32 to 3.61), interpregnancy interval (IPI) <2 years (OR 2.99, 95% CI 1.98 to 4.50), previous abortion (OR 2.35, 95% CI 1.76 to 3.14), previous preterm birth (OR 5.72, 95% CI 3.44 to 9.50), prior PROM (OR 3.95, 95% CI 2.48 to 6.28), history of caesarean section (OR 3.06, 95% CI 1.72 to 5.43), gestational hypertension (OR 3.84, 95% CI 2.36 to 6.24), gestational diabetes mellitus (GDM) (OR 2.16, 95% CI 1.44 to 3.23), abnormal vaginal discharge (OR 2.17, 95% CI 1.45 to 3.27), reproductive tract infection (OR 2.16, 95% CI 1.70 to 2.75), malpresentation (OR 2.26, 95% CI 1.78 to 2.85) and increased abdominal pressure (OR 1.45, 95% CI 1.07 to 1.97). The sensitivity analysis showed that the pooled estimates were stable. CONCLUSIONS: This meta-analysis indicated that low BMI, IPI <2 years, previous abortion, previous preterm birth, prior PROM, history of caesarean section, gestational hypertension, GDM, abnormal vaginal discharge, reproductive tract infection, malpresentation and increased abdominal pressure might be associated with a greater risk of PROM. Associations between smoking status, short cervical length, fine particulate matter (PM2.5) and PROM require further investigation. PROSPERO REGISTRATION NUMBER: CRD42022381485.
Subject(s)
Fetal Membranes, Premature Rupture , Humans , Fetal Membranes, Premature Rupture/epidemiology , Pregnancy , Female , Risk Factors , Body Mass Index , Diabetes, Gestational/epidemiology , Cesarean Section/statistics & numerical dataABSTRACT
Preterm Premature Rupture of Membranes (PPROM) is defined as the rupture of fetal membranes prior to the onset of labor, before 37 weeks gestation and remains a significant obstetric complication of pregnancy with high rates of perinatal morbidity and mortality worldwide. The aim of our study was to establish the determinants of PPROM <34 weeks at this GJG MRH hospital which has a high incidence of PPROM. It was a descriptive , retrospective chart review of women diagnosed with PPROM over a 1 year period from 1st of January 2018 to 31st of December 2018. Detailed clinical and demographic information was recorded. Statistical analysis was carried out using SPSS (Version 28.0 IBM, Armonk, New York, USA) of 7071 singleton deliveries, 428 were diagnosed with PPROM. Majority (69%) were between the age groups of 21 to 30 years. Women belonging to age groups of <20 years and >=30 years, including women who attend antenatal clinics >=4 times were less likely to experience PPROM. History of abortions, previous preterm delivery, previous PPROM and women who had infectious components were determinants of PPROM. Among the neonates delivered by women who had PPROM, 56.3% had an unfavorable outcome.
La rupture prématurée des membranes (PPROM) est définie comme la rupture des membranes fÅtales avant le début du travail, avant 37 semaines de gestation et reste une complication obstétricale importante de la grossesse avec des taux élevés de morbidité et de mortalité périnatales dans le monde. Le but de notre étude était d'établir les déterminants de la PPROM <34 semaines dans cet hôpital GJG MRH qui a une incidence élevée de PPROM. Il s'agissait d'un examen descriptif et rétrospectif des dossiers de femmes diagnostiquées avec PPROM sur une période d'un an allant du 1er janvier 2018 au 31 décembre 2018. Des informations cliniques et démographiques détaillées ont été enregistrées. L'analyse statistique a été réalisée à l'aide de SPSS (version 28.0 IBM, Armonk, New York, USA) sur 7 071 accouchements uniques, 428 ont été diagnostiqués avec PPROM. La majorité (69 %) appartenait au groupe d'âge de 21 à 30 ans. Les femmes appartenant aux groupes d'âge <20 ans et >=30 ans, y compris les femmes qui fréquentent les cliniques prénatales >=4 fois, étaient moins susceptibles de souffrir de PPROM. Les antécédents d'avortements, les accouchements prématurés antérieurs, les antécédents de PPROM et les femmes présentant des composantes infectieuses étaient des déterminants de la PPROM. Parmi les nouveau-nés accouchés par des femmes atteintes de PPROM, 56,3 % ont eu une évolution défavorable.
Subject(s)
Fetal Membranes, Premature Rupture , Premature Birth , Infant, Newborn , Pregnancy , Female , Humans , Young Adult , Adult , Premature Birth/epidemiology , Pregnancy Outcome/epidemiology , Retrospective Studies , South Africa/epidemiology , Fetal Membranes, Premature Rupture/epidemiology , HospitalsABSTRACT
BACKGROUND: Prematurity is considered to be the leading cause of death in children under 5 years of age, with one child dying every 2 s. Smoking is known to be one of the factors associated with prematurity, with both immediate and late consequences. However, it is difficult to obtain concrete data on the relationship between smoking and spontaneous preterm birth. OBJECTIVE: The aim of this study was to evaluate the influence of active and passive smoking on spontaneous preterm birth. METHODS: This was a multicenter, cross-sectional complementary study that included data on preterm births in 20 maternity hospitals in Brazil between 2011 and 2012. The relationship between smoking category (people who smoke [PWS]; people who smoke indirectly [PWSI]; and people who do not smoke [PWDNS]) and sociodemographic characteristics, birth, and neonatal data was assessed. Statistical analysis was performed using frequencies, percentages, the χ2 test, and stepwise comparisons, with a significance level of 5%. RESULTS: The original study included 5295 pregnant participants and their preterm infants. There were 1491 spontaneous preterm births (SPBs); 1191 preterm rupture of membranes; 1468 therapeutic preterm births; and 1146 term births. The proportion of women who were PWS during pregnancy was 13.5%, and 31.6% were PWSI. Pregnant individuals who smoked and who smoked indirectly had a higher incidence of SPBs (61.2%) compared with PWDNS (48.4%; P < 0.0001); however, multivariate analysis did not confirm causality. CONCLUSIONS: This study did not confirm that smoking during pregnancy increases the risk of SPB. PWSI also did not have an increased incidence of spontaneous preterm birth or adverse neonatal outcomes.
Subject(s)
Premature Birth , Smoking , Tobacco Smoke Pollution , Humans , Female , Premature Birth/epidemiology , Pregnancy , Cross-Sectional Studies , Brazil/epidemiology , Tobacco Smoke Pollution/adverse effects , Tobacco Smoke Pollution/statistics & numerical data , Adult , Infant, Newborn , Smoking/epidemiology , Smoking/adverse effects , Young Adult , Risk Factors , Fetal Membranes, Premature Rupture/epidemiologyABSTRACT
Objective: To investigate the feasibility of expectant management of different degrees of vaginal fluid in pregnant women with premature rupture of membranes in the second trimester. Methods: A retrospective cohort study was conducted to collect 103 pregnant women who were diagnosed with premature rupture of membranes in the second trimester of pregnancy and insisted on continuing the pregnancy in Shanxi Bethune Hospital from July 2012 to July 2022. According to the degree of vaginal fluid, pregnant women were divided into rupture group (with typical vaginal fluid, 48 cases) and leakage group (without typical vaginal fluid, 55 cases). The rupture latency (the time from rupture of membranes to termination of pregnancy), gestational weeks of termination, indications and methods of termination of pregnancy, maternal infection related indicators and perinatal outcomes were compared between the two groups. Univariate regression model was used to analyze the correlation between different degrees of vaginal fluid in pregnant women with premature rupture of membranes and maternal and neonatal outcomes. Results: (1) Obstetric indicators: there was no significant difference in the gestational age of rupture of membranes between the two groups (P>0.05). However, the proportion of rupture latency >28 days in the leakage group was significantly higher than that in the rupture group [42% (23/55) vs 13% (6/48); χ2=33.673, P<0.001], and the incidence of pregnancy termination ≥28 weeks was significantly higher [47% (26/55) vs 19% (9/48); χ2=9.295, P=0.002]. (2) Indications and methods of termination: the incidence of progressive reduction of amniotic fluid as the indication for termination in the leakage group was significantly lower than that in the rupture group [22% (12/55) vs 42% (20/48); χ2=4.715, P=0.030], and the incidence of full-term termination in the leakage group was significantly higher than that in the rupture group [31% (17/55) vs 12% (6/48); χ2=5.008, P=0.025], while there were no significant differences in the indications of termination of pregnancy, including amniotic cavity infection, uterine contraction failure and fetal distress between the two groups (all P>0.05). The incidence of induced labor or spontaneous contraction in the leakage group was significantly lower than that in the rupture group [53% (29/55) vs 81% (39/48); χ2=9.295, P=0.002], while the cesarean section rate and vaginal delivery rate were similar between the two groups (both P>0.05). (3) Infection related indicators: the incidence of amniotic cavity infection in the leakage group was significantly higher than that in the rupture group [31% (17/55) vs 13% (6/48); χ2=4.003, P=0.045]. However, there were no significant differences in the elevation of inflammatory indicators, the positive rate of cervical secretion bacterial culture and the incidence of tissue chorioamnionitis between the two groups (all P>0.05). (4) Perinatal outcomes: the live birth rate in the leakage group was significantly higher than that in the rupture group [51% (28/55) vs 27% (13/48); χ2=5.119, P=0.024]. The proportion of live births with 1-minute Apgar score >7 in the leakage group was significantly higher than that in the rupture group [38% (21/55) vs 17% (8/48); χ2=4.850, P=0.028]. However, there were no significant differences in the birth weight of live births and the incidence of neonatal complications between the two groups (all P>0.05). (5) Univariate regression analysis showed that compared with the rupture group, the leakage group had a higher risk of pregnancy termination at ≥28 gestational weeks (RR=2.521, 95%CI: 1.314-4.838; P=0.002), amniotic infection (RR=2.473, 95%CI: 1.061-5.764; P=0.025), perinatal survival (RR=1.880, 95%CI: 1.104-3.199; P=0.014). Conclusion: Compared with pregnant women with typical vaginal fluid in the second trimester of premature rupture of membranes, expectant treatment for pregnant women with atypical vaginal fluid is more feasible, which could effectively prolong the gestational weeks and improve the perinatal live birth rate.
Subject(s)
Chorioamnionitis , Fetal Membranes, Premature Rupture , Premature Birth , Infant, Newborn , Pregnancy , Female , Humans , Pregnancy Trimester, Second , Pregnant Women , Cesarean Section , Feasibility Studies , Fetal Membranes, Premature Rupture/epidemiology , Fetal Membranes, Premature Rupture/therapy , Watchful Waiting , Retrospective Studies , Premature Birth/epidemiology , Chorioamnionitis/epidemiology , Gestational Age , Pregnancy OutcomeABSTRACT
OBJECTIVE: To compare preterm birth rates and reasons before and during the COVID-19-pandemic using a monocentric, retrospective study. METHODS: Univariate analysis identified differences in rates and reasons for preterm birth and neonatal outcomes between the pre-pandemic period (January 1, 2018 to December 31, 2019) and during the pandemic (January 1, 2020 to December 31, 2021) among all births at our tertiary obstetrical center, the University Hospital of Essen. RESULTS: The cohort consisted of 6086 deliveries with 593 liveborn preterm singletons. During the pandemic, the incidence of preterm birth decreased (10.7% vs. 8.6%; odds ratio [OR] 0.79; 95% confidence interval [CI] 0.66-0.93). Spontaneous preterm birth (43.2% vs. 52.3%; OR 1.47; 95% CI 1.05-2.03), and placenta accreta spectrum disorder (3.7% vs. 8.2%; OR 2.36; 95% CI 1.15-4.84) were more common reasons for preterm birth. Placental dysfunction was a less common reason (34.1% vs. 24.3%; OR 0.62; 95% CI 0.43-0.90). Incidences of preterm premature rupture of membranes (28.13% vs. 40.25%; OR 1.72; 95% CI 1.12-2.43) and oligo-/anhydramnios (3.98% vs. 7.88%; OR 2.06; 95% CI 1.02-4.21) increased. Iatrogenic preterm birth decreased (54.5% vs. 49.5%; OR 0.81; 95% CI 0.58-1.13). Stillbirth rates did not change significantly. Among term births, there were fewer spontaneous deliveries (71.0% vs. 65.8%; OR 0.78; 95% CI 0.69-0.88), and more elective (12.3% vs. 15.1%; OR 1.26; 95% CI 1.07-1.50) and unplanned (9.3% vs. 10.9%; OR 1.19; 95% CI 0.98-1.45) cesarean sections. During the pandemic, more term newborns were admitted to neonatal intensive care (1.4% vs. 2.5%; OR 1.86; 95% CI 1.20-2.88). CONCLUSION: Our results, in line with data from other high-income countries, suggest that the likely reason for the decreased preterm birth rates is the underdiagnosis of pregnancy complications.
Subject(s)
COVID-19 , Premature Birth , Tertiary Care Centers , Humans , Female , Pregnancy , COVID-19/epidemiology , Premature Birth/epidemiology , Retrospective Studies , Adult , Germany/epidemiology , Tertiary Care Centers/statistics & numerical data , Infant, Newborn , SARS-CoV-2 , Incidence , Pregnancy Outcome/epidemiology , Placenta Accreta/epidemiology , Fetal Membranes, Premature Rupture/epidemiologyABSTRACT
OBJECTIVE: To assess the association between clinical chorioamnionitis and neurodevelopmental disorders at 5 years of age in children born preterm. STUDY DESIGN: EPIPAGE 2 is a national, population-based cohort study of children born before 35 weeks of gestation in France in 2011. We included infants born alive between 240/7 and 346/7 weeks after preterm labor or preterm premature rupture of membranes. Clinical chorioamnionitis was defined as maternal fever before labor (>37.8°C) with ≥2 of the following criteria: maternal tachycardia, hyperleukocytosis, uterine contractions, purulent amniotic fluid, or fetal tachycardia. The primary outcome was a composite, including cerebral palsy, coordination disorders, cognitive disorders, sensory disorders, or behavioral disorders. We also analyzed each of these disorders separately as secondary outcomes. We performed a multivariable analysis using logistic regression models. We accounted for the nonindependence of twins and missing data by generalized estimating equation models and multiple imputations, respectively. RESULTS: Among 2927 children alive at 5 years of age, 124 (3%) were born in a context of clinical chorioamnionitis. Overall, 8.2% and 9.6% of children exposed and unexposed, respectively, to clinical chorioamnionitis had moderate-to-severe neurodevelopmental disorders. After multiple imputations and multivariable analysis, clinical chorioamnionitis was not associated with the occurrence of moderate-to-severe neurodevelopmental disorders (aOR, 0.9; 95% CI, 0.5-1.8). CONCLUSIONS: We did not find any association between clinical chorioamnionitis and neurodevelopmental disorders at 5 years of age in children born at <35 weeks of gestation after preterm labor or preterm premature rupture of membrane.
Subject(s)
Chorioamnionitis , Fetal Membranes, Premature Rupture , Premature Birth , Infant, Newborn , Infant , Pregnancy , Child , Female , Humans , Aged, 80 and over , Chorioamnionitis/epidemiology , Cohort Studies , Gestational Age , Tachycardia , Fetal Membranes, Premature Rupture/epidemiologyABSTRACT
BACKGROUND: Individuals hospitalized with preterm prelabor rupture of membranes are often advised to limit their activity or adhere to bed rest. Some evidence suggests that greater activity is associated with longer latency and improved outcomes, but no high-quality evidence from a randomized controlled trial exists. OBJECTIVE: This study aimed to evaluate whether encouragement to ambulate at least 2000 steps daily affects latency among individuals with preterm prelabor rupture of membranes compared with usual care. STUDY DESIGN: This was a multisite unblinded, 2-arm randomized trial of individuals at 23 0/7 to 35 0/7 weeks of gestation undergoing inpatient expectant management of preterm prelabor rupture of membranes with planned delivery at least 7 days away. Each participant wore a Fitbit Inspire that tracked steps. The intervention arm was encouraged (verbal and Fitbit-based reminders) to reach a goal of 2000 steps per day. The usual-care arm was allowed ad libitum activity with no step goal or reminders. The primary outcome was latency (days) from randomization to delivery. Secondary analyses included composite neonatal and maternal clinical outcomes and maternal mental health survey results. Statistical analyses were conducted with an intent-to-treat approach under a Bayesian framework using neutral priors (a priori assumed 50:50 likelihood of longer latency in either arm). A total of 100 participants were required to have 80% power to demonstrate a 4-day difference in latency with 75% certainty (Bayesian probability). RESULTS: Among 163 eligible individuals, 100 (61%) were randomized, and after loss to follow-up, 95 were analyzed. Gestational age at randomization was 29 3/7 weeks (interquartile range, 26 2/7 to 31 5/7) in the intervention arm and 27 4/7 weeks (interquartile range, 25 4/7 to 29 6/7) in the usual-care arm. Median step counts were 1690 per day in the intervention arm (interquartile range, 1031-2641) and 1338 per day in the usual-care arm (interquartile range, 784-1913). Median days of latency were 9 days in the intervention arm (interquartile range, 4-17) and 6 days in the usual-care arm (interquartile range, 2-14). The primary analysis indicated a 65% posterior probability that the intervention increased latency relative to usual care (posterior relative risk, 1.09; 95% credible interval, 0.70-1.71). The relative risk was 0.55 (95% credible interval, 0.32-0.82) for the composite neonatal adverse outcome, with 99% posterior probability of intervention benefit, and was 0.94 (95% credible interval, 0.72-1.20) for the composite maternal adverse outcome, with 70% posterior probability of intervention benefit. There was a 94% posterior probability of the intervention arm having a greater decrease in maternal stress score from baseline to before delivery compared with the usual-care arm (mean arm difference, 3.24 points [95% credible interval, -7.23 to 0.79]). Adjustment for gestational age at randomization had minimal impact on secondary outcome results. CONCLUSION: Individuals with preterm prelabor rupture of membranes randomized to encouragement to ambulate had a longer latency to delivery and improved neonatal and mental health outcomes, with similar maternal clinical outcomes compared with usual care.