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1.
BMC Pregnancy Childbirth ; 24(1): 455, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38951754

ABSTRACT

BACKGROUND: The rates of labor induction and cesarean delivery is rising worldwide. With the confluence of these trends, the labor induction rate in trials of labor after cesarean can be as high as 27-32.7%. Induction of labor after one previous cesarean (IOLAC) is a high-risk procedure mainly due to the higher risk of uterine rupture. Nevertheless, the American College of Obstetricians and Gynecologists considers IOLAC as an option in motivated and informed women in the appropriate care setting. We sought to identify predictors of a composite of maternal and newborn adverse outcomes following IOLAC. METHODS: The electronic medical records of women who delivered between January 2018 to September 2022 in a Malaysian university hospital were screened to identify cases of IOLAC. A case is classified as a composite adverse outcome if at least one of these 11 adverse outcomes of delivery blood loss ≥ 1000 ml, uterine scar complications, cord prolapse or presentation, placenta abruption, maternal fever (≥ 38 0C), chorioamnionitis, intensive care unit (ICU) admission, Apgar score < 7 at 5 min, umbilical artery cord artery blood pH < 7.1 or base excess ≤-12 mmol/l, and neonatal ICU admission was present. An unplanned cesarean delivery was not considered an adverse outcome as the practical management alternative for a clinically indicated IOLAC was a planned cesarean. Bivariate analysis of participants' characteristics was performed to identify predictors of their association with composite adverse outcome. Characteristics with crude p < 0.10 on bivariate analysis were incorporated into a multivariable binary logistic regression analysis model. RESULTS: Electronic medical records of 19,064 women were screened. 819 IOLAC cases and 98 cases with composite adverse outcomes were identified. Maternal height, ethnicity, previous vaginal delivery, indication of previous cesarean, indication for IOLAC, and method of IOLAC had p < 0.10 on bivariate analysis and were incorporated into a multivariable binary logistic regression analysis. After adjustment, only maternal height and IOLAC by vaginal dinoprostone compared to Foley balloon remained significant at p < 0.05. Post hoc adjusted analysis that included all unplanned cesarean as an added qualifier for composite adverse outcome showed higher body mass index, short stature (< 157 cm), not of Chinese ethnicity, no prior vaginal delivery, prior cesarean indicated by labor dystocia, and less favorable Bishop score (< 6) were independent predictors of the expanded composite adverse outcome. CONCLUSION: Shorter women and IOLAC by vaginal dinoprostone compared to Foley balloon were independently predictive of composite of adverse outcome.


Shorter stature and dinoprostone labor induction are independent predictors of a composite maternal-newborn adverse outcome excluding unplanned cesarean delivery.


Subject(s)
Dinoprostone , Labor, Induced , Vaginal Birth after Cesarean , Humans , Female , Pregnancy , Labor, Induced/adverse effects , Labor, Induced/methods , Retrospective Studies , Adult , Dinoprostone/administration & dosage , Vaginal Birth after Cesarean/adverse effects , Vaginal Birth after Cesarean/statistics & numerical data , Infant, Newborn , Oxytocics/administration & dosage , Oxytocics/adverse effects , Oxytocics/therapeutic use , Administration, Intravaginal , Pregnancy Outcome/epidemiology , Cesarean Section/statistics & numerical data , Malaysia/epidemiology , Risk Factors
2.
Ghana Med J ; 58(1): 44-52, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38957282

ABSTRACT

Objective: To compare cervical ripening time with the use of vaginal Misoprostol plus Hyoscine-N-Butylbromide, with vaginal Misoprostol alone. Design: A double-blind randomized controlled trial with Pan-African Clinical Trials Registry (PACTR) approval number PACTR202112821475292. Setting: Federal Medical Centre, Asaba, Nigeria. Participants: A total of 126 eligible antenatal patients for cervical ripening were enrolled. Interventions: Participants in Group A had 25µg of vaginal misoprostol with 1ml of intramuscular placebo, and those in Group B had 25µg of vaginal misoprostol with 20mg of Intramuscular Hyoscine (1 ml). Oxytocin infusion was used when indicated, and the labour was supervised as per departmental protocol. Main outcome measure: Cervical ripening time. Results: The mean cervical ripening time was statistically significantly shorter in the hyoscine group (8.48±4.36 hours) than in the placebo group (11.40±7.33 hours); p-value 0.02, 95% CI 0.80-5.05. There was no statistically significant difference in the mean induction-delivery interval in Group A (7.38±5.28 hours) compared to Group B (7.75±5.04 hours), with a value of 0.54. The mode of delivery was comparable. However, women in Group B (53, 84.1%) achieved more vaginal deliveries than women in Group A (50, 79.4%); p-value 0.49. Thirteen women in Group A (20.6%) had a caesarean section, while ten women (15.9%) in Group B had a caesarean section (p-value 0.49, RR 0.94, CI 0.80-1.11). Adverse maternal and neonatal outcomes were not statistically significant between the two groups. Conclusion: Intramuscular hyoscine was effective in reducing cervical ripening time when used as an adjunct to vaginal Misoprostol, with no significant adverse maternal or neonatal outcome. Funding: None declared.


Subject(s)
Cervical Ripening , Misoprostol , Oxytocics , Humans , Female , Pregnancy , Misoprostol/administration & dosage , Double-Blind Method , Cervical Ripening/drug effects , Adult , Administration, Intravaginal , Oxytocics/administration & dosage , Young Adult , Butylscopolammonium Bromide/administration & dosage , Nigeria , Labor, Induced/methods , Time Factors , Drug Therapy, Combination
3.
Arch Gynecol Obstet ; 310(1): 337-344, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38829389

ABSTRACT

PURPOSE: To compare perinatal outcomes between active and routine management in true knot of the umbilical cord (TKUC). METHODS: A retrospective study of singletons born beyond 22 6/7 weeks with TKUC. Active management included weekly fetal heart rate monitoring(FHRM) ≥ 30 weeks and labor induction at 36-37 weeks. Outcomes in active and routine management were compared, including composite asphyxia-related adverse outcome, fetal death, labor induction, Cesarean section (CS) or Instrumental delivery due to non-reassuring fetal heart rate (NRFHR), Apgar5 score < 7, cord Ph < 7, neonatal intensive care unit (NICU) admission and more. RESULTS: The Active (n = 59) and Routine (n = 1091) Management groups demonstrated similar rates of composite asphyxia-related adverse outcome (16.9% vs 16.8%, p = 0.97). Active Management resulted in higher rates of labor induction < 37 weeks (22% vs 1.7%, p < 0.001), CS (37.3% vs 19.2%, p = 0.003) and NICU admissions (13.6% vs 3%, p < 0.001). Fetal death occurred exclusively in the Routine Management group (1.8% vs 0%, p = 0.6). CONCLUSION: Compared with routine management, weekly FHRM and labor induction between 36 and 37 weeks in TKUC do not appear to reduce neonatal asphyxia. In its current form, active management is associated with higher rates of CS, induced prematurity and NICU admissions. Labor induction before 37 weeks should be avoided.


Subject(s)
Cesarean Section , Heart Rate, Fetal , Labor, Induced , Umbilical Cord , Humans , Retrospective Studies , Female , Pregnancy , Umbilical Cord/surgery , Infant, Newborn , Adult , Labor, Induced/methods , Cesarean Section/statistics & numerical data , Apgar Score , Intensive Care Units, Neonatal , Fetal Death , Pregnancy Outcome , Asphyxia Neonatorum/therapy
4.
BMC Pregnancy Childbirth ; 24(1): 403, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38824569

ABSTRACT

BACKGROUND: The practice of intrapartum use of oxytocin for induction and augmentation of labour is increasing worldwide with documented wide variations in clinical use, especially dose administrations. There is also evidence of intrapartum use by unauthorized cadre of staff. AIM: This study assessed the patterns - frequency of intrapartum use of oxytocin, the doses and routes of administration for induction and augmentation of labour, and identified the predictors of oxytocin use for induction and augmentation of labour by healthcare providers in Nigeria. METHODS: This was a cross-sectional study conducted among healthcare providers - doctors, nurses/midwives and community health workers (CHWs) in public and private healthcare facilities across the country's six geopolitical zones. A multistage sampling technique was used to select 6,299 eligible healthcare providers who use oxytocin for pregnant women during labour and delivery. A self-administered questionnaire was used to collect relevant data and analysed using STATA 17 statistical software. Summary and inferential statistics were done and further analyses using multivariable regression models were performed to ascertain independent predictor variables of correct patterns of intrapartum oxytocin usage. The p-value was set at < 0.05. RESULTS: Of the 6299 respondents who participated in the study, 1179 (18.7%), 3362 (53.4%), and 1758 (27.9%) were doctors, nurses/midwives and CHWs, respectively. Among the respondents, 4200 (66.7%) use oxytocin for augmentation of labour while 3314 (52.6%) use it for induction of labour. Of the 1758 CHWs, 37.8% and 49% use oxytocin for induction and augmentation of labour, respectively. About 10% of the respondents who use oxytocin for the induction or augmentation of labour incorrectly use the intramuscular route of administration and about 8% incorrectly use intravenous push. Being a doctor, and a healthcare provider from government health facilities were independent positive predictors of the administration of correct dose oxytocin for induction and augmentation of labour. The CHWs were most likely to use the wrong route and dose administration of oxytocin for the induction and augmentation of labour. CONCLUSION: Our study unveiled a concerning clinical practice of intrapartum oxytocin use by healthcare providers in Nigeria - prevalence of intrapartum use of oxytocin, inappropriate routes of administration for induction and augmentation of labour, varied and inappropriately high start dose of administration including unauthorized and high intrapartum use of oxytocin among CHWs.


Subject(s)
Health Personnel , Labor, Induced , Oxytocics , Oxytocin , Humans , Oxytocin/administration & dosage , Nigeria , Female , Pregnancy , Cross-Sectional Studies , Labor, Induced/methods , Labor, Induced/statistics & numerical data , Oxytocics/administration & dosage , Adult , Health Personnel/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Surveys and Questionnaires , Labor, Obstetric , Male , Young Adult
5.
Midwifery ; 135: 104026, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38781793

ABSTRACT

OBJECTIVE: Assess the outcome of induction of labour (IOL) with a Foley catheter in pregnancies at 41 weeks in midwifery-led care setting compared to consultant-led care setting. DESIGN: Mixed-methods cohort study at a midwifery - hospital partnership in Amsterdam, the Netherlands. SETTING AND PARTICIPANTS: Prospectively, women undergoing IOL in midwifery-led care were recruited at a secondary hospital. This group was compared to a retrospective cohort, in which IOL was exclusively performed under consultant-led care. MEASUREMENTS AND FINDINGS: We compared 320 women whose induction started in midwifery-led care to a historical cohort of 320 women induced for the same reason under consultant-led care. Both groups exhibited similar rates of spontaneous vaginal births (64.2 %vs62.5 %). Caesarean section and assisted vaginal birth rates did not significantly differ. Maternal adverse outcomes were comparable, while neonatal adverse outcomes were significantly higher in the midwifery-led care group (8.1 %vs3.8 %; OR 2.27, 95 % CI 1.12-4.58). The use of pain relief was significantly lower in midwife-led care (65.3 %vs75.3 %; OR 0.62, 95 % CI 0.44-0.87). 20.6 % of births occurred in midwife-led care. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: In this single-centre study, spontaneous vaginal birth rates following IOL with a Foley catheter were similar between midwife- and consultant-led care. However, the midwife-led group showed a higher risk of adverse neonatal outcomes, mainly early onset neonatal sepsis, with a minority eventually delivering under midwife-led care. Implications highlight the need for broader research, validation across diverse settings and exploration of patient and healthcare worker perspectives to refine the evolving midwifery-led care model.


Subject(s)
Labor, Induced , Midwifery , Humans , Female , Labor, Induced/statistics & numerical data , Labor, Induced/methods , Pregnancy , Netherlands , Adult , Midwifery/methods , Midwifery/statistics & numerical data , Retrospective Studies , Cohort Studies , Prospective Studies , Pregnancy Outcome/epidemiology , Urinary Catheterization/statistics & numerical data , Urinary Catheterization/methods , Urinary Catheterization/adverse effects , Urinary Catheterization/instrumentation
6.
PLoS One ; 19(5): e0304631, 2024.
Article in English | MEDLINE | ID: mdl-38820427

ABSTRACT

BACKGROUND: The Maternal and Perinatal Death Surveillance and Response (MPDSR) was introduced in Kenya in 2016 and implemented at Kiambu Level 5 Hospital (KL5H) three years later in 2019. During a routine MPDSR meeting at KL5H, committee members identified a possible link between the off-label use of 200mcg misoprostol tablets divided eight times to achieve the necessary dose for labour induction (25mcg) and maternal deaths. Following this, an administrative decision was made to switch from misoprostol to dinoprostone for the induction of labour in June of 2019. This study aimed to assess the overall impact of MPDSR as well as the effect of replacing misoprostol with dinoprostone on uterine rupture, maternal and neonatal deaths at KL5H. METHODS: We conducted a retrospective cohort study of women who gave birth at KL5H between January 2018 and December 2020. We defined the pre-intervention period as January 2018-June 2019, and the intervention period as July 2019-December 2020. We randomly selected the records of 411 mothers, 167 from the pre-intervention period and 208 from the intervention period, all of whom were induced. We used Bayes-Poisson Generalised Linear Models to fit the risk of uterine rupture, maternal and perinatal death. 12 semi-structured key person questionnaires was used to describe staff perspectives regarding the switch from misoprostol to dinoprostone. Inductive and deductive data analysis was done to capture the salient emerging themes. RESULTS: We reviewed 411 patient records and carried out 12 key informant interviews. Mothers induced with misoprostol (IRR = 3.89; CI = 0.21-71.6) had an increased risk of death while mothers were less likely to die if they were induced with dinoprostone (IRR = 0.23; CI = 0.01-7.12) or had uterine rupture (IRR = 0.56; CI = 0.02-18.2). The risk of dying during childbearing increased during Jul 2019-Dec 2020 (IRR = 5.43, CI = 0.68-43.2) when the MPDSR activities were strengthened. Induction of labour (IRR = 1.01; CI = 0.06-17.1) had no effect on the risk of dying from childbirth in our setting. The qualitative results exposed that maternity unit staff preferred dinoprostone to misoprostol as it was thought to be more effective (fewer failed inductions) and safer, regardless of being more expensive compared to misoprostol. CONCLUSION: While the period immediately following the implementation of MPDSR at KL5H was associated with an increased risk of death, the switch to dinoprostone for labour induction was associated with a lower risk of maternal and perinatal death. The use of dinoprostone, however, was linked to an increased risk of uterine rupture, possibly attributed to reduced labour monitoring given that staff held the belief that it is inherently safer than misoprostol. Consequently, even though the changeover was warranted, further investigation is needed to determine the reasons behind the rise in maternal mortalities, even though the MPDSR framework appeared to have been put in place to quell such an increase.


Subject(s)
Dinoprostone , Labor, Induced , Misoprostol , Oxytocics , Humans , Misoprostol/administration & dosage , Misoprostol/therapeutic use , Female , Labor, Induced/methods , Pregnancy , Retrospective Studies , Adult , Dinoprostone/administration & dosage , Oxytocics/administration & dosage , Oxytocics/adverse effects , Oxytocics/therapeutic use , Uterine Rupture , Infant, Newborn , Young Adult , Perinatal Death , Maternal Mortality
7.
BMC Pregnancy Childbirth ; 24(1): 401, 2024 May 31.
Article in English | MEDLINE | ID: mdl-38822253

ABSTRACT

BACKGROUND: Previous studies had found that the mechanical methods were as effective as pharmacological methods in achieving vaginal delivery. However, whether balloon catheter induction is suitable for women with severe cervical immaturity and whether it will increase the related risks still need to be further explored. RESEARCH AIM: To evaluate the efficacy and safety of Foley catheter balloon for labor induction at term in primiparas with different cervical scores. METHODS: A total of 688 primiparas who received cervical ripening with a Foley catheter balloon were recruited in this study. They were divided into 2 groups: Group 1 (Bishop score ≤ 3) and Group 2 (3 < Bishop score < 7). Detailed medical data before and after using of balloon were faithfully recorded. RESULTS: The cervical Bishop scores of the two groups after catheter placement were all significantly higher than those before (Group 1: 5.49 ± 1.31 VS 2.83 ± 0.39, P<0.05; Group 2: 6.09 ± 1.00 VS 4.45 ± 0.59, P<0.05). The success rate of labor induction in group 2 was higher than that in group 1 (P<0.05). The incidence of intrauterine infection in Group 1 was higher than that in Group 2 (18.3% VS 11.3%, P<0.05). CONCLUSION: The success rates of induction of labor by Foley catheter balloon were different in primiparas with different cervical conditions, the failure rate of induction of labor and the incidence of intrauterine infection were higher in primiparas with severe cervical immaturity.


Subject(s)
Cervical Ripening , Cervix Uteri , Labor, Induced , Humans , Labor, Induced/methods , Female , Pregnancy , Retrospective Studies , Adult , Parity , Catheterization/methods , Term Birth , Young Adult , Urinary Catheterization/methods , Urinary Catheterization/instrumentation , Catheters
8.
Clin Obstet Gynecol ; 67(2): 418-425, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38597187

ABSTRACT

In 2003, in the context of a national research funding program in which obstetric research was prioritized, several perinatal centers took the initiative to jointly submit a number of applications to the subsidy programs of Effectiveness Research and Prevention of ZonMw. This has led to the funding of the Obstetric Consortium with several projects, including the "Hypertension in Pregnancy Intervention Trial At Term" and the "Disproportionate Intrauterine Growth Intervention Trial At Term" studies. The studies showed that induction of labor for hypertension and growth restriction at term was the appropriate management. Subsequent implementation improved maternal and perinatal outcomes.


Subject(s)
Fetal Growth Retardation , Hypertension, Pregnancy-Induced , Humans , Pregnancy , Female , Fetal Growth Retardation/prevention & control , Hypertension, Pregnancy-Induced/prevention & control , Hypertension, Pregnancy-Induced/therapy , Labor, Induced/methods , Infant, Newborn
9.
Am J Obstet Gynecol ; 230(3S): S696-S715, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38462253

ABSTRACT

OBJECTIVE: Several systematic reviews and meta-analyses have been conducted to summarize the evidence for the efficacy of various labor induction agents. However, the most effective agents or strategies have not been conclusively determined. We aimed to perform a meta-review and network meta-analysis of published systematic reviews to determine the efficacy and safety of currently employed pharmacologic, mechanical, and combined methods of labor induction. DATA SOURCES: With the assistance of an experienced medical librarian, we performed a systematic search of the literature using PubMed, EMBASE, and the Cochrane Central Register of Control Trials. We systematically searched electronic databases from inception to May 31, 2021. STUDY ELIGIBILITY CRITERIA: We considered systematic reviews and meta-analyses of randomized controlled trials comparing different agents or methods for inpatient labor induction. METHODS: We conducted a frequentist random-effects network meta-analysis employing data from randomized controlled trials of published systematic reviews. We performed direct pairwise meta-analyses to compare the efficacy of the various labor induction agents and placebo or no treatment. We performed ranking to determine the best treatment using the surface under the cumulative ranking curve. The main outcomes assessed were cesarean delivery, vaginal delivery within 24 hours, operative vaginal delivery, hyperstimulation, neonatal intensive care unit admissions, and Apgar scores of <7 at 5 minutes of birth. RESULTS: We included 11 systematic reviews and extracted data from 207 randomized controlled trials with a total of 40,854 participants. When assessing the efficacy of all agents and methods, the combination of a single-balloon catheter with misoprostol was the most effective in reducing the odds of cesarean delivery and vaginal birth >24 hours (surface under the cumulative ranking curve of 0.9 for each). Among the pharmacologic agents, low-dose vaginal misoprostol was the most effective in reducing the odds of cesarean delivery, whereas high-dose vaginal misoprostol was the most effective in achieving vaginal delivery within 24 hours (surface under the cumulative ranking curve of 0.9 for each). Single-balloon catheter (surface under the cumulative ranking curve of 0.8) and double-balloon catheter (surface under the cumulative ranking curve of 0.9) were the most effective in reducing the odds of operative vaginal delivery and hyperstimulation. Buccal or sublingual misoprostol (surface under the cumulative ranking curve of 0.9) and the combination of single-balloon catheter and misoprostol (surface under the cumulative ranking curve of 0.9) most effectively reduced the odds of abnormal Apgar scores and neonatal intensive care unit admissions. CONCLUSION: The combination of a single-balloon catheter with misoprostol was the most effective method in reducing the odds for cesarean delivery and prolonged time to vaginal delivery. This method was associated with a reduction in admissions to the neonatal intensive care unit.


Subject(s)
Misoprostol , Oxytocics , Pregnancy , Female , Infant, Newborn , Humans , Misoprostol/therapeutic use , Oxytocics/therapeutic use , Network Meta-Analysis , Labor, Induced/methods , Urinary Catheters
10.
Am J Obstet Gynecol ; 230(3S): S716-S728.e61, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38462254

ABSTRACT

OBJECTIVE: Several systematic reviews and meta-analyses have summarized the evidence on the efficacy and safety of various outpatient cervical ripening methods. However, the method with the highest efficacy and safety profile has not been determined conclusively. We performed a systematic review and network meta-analysis of published randomized controlled trials to assess the efficacy and safety of cervical ripening methods currently employed in the outpatient setting. DATA SOURCES: With the assistance of an experienced medical librarian, we performed a systematic search of the literature using MEDLINE, Embase, Scopus, Web of Science, Cochrane Library, and ClinicalTrials.gov. We systematically searched electronic databases from inception to January 14, 2020. STUDY ELIGIBILITY CRITERIA: We considered randomized controlled trials comparing a variety of methods for outpatient cervical ripening. METHODS: We conducted a frequentist random effects network meta-analysis employing data from randomized controlled trials. We performed a direct, pairwise meta-analysis to compare the efficacy of various outpatient cervical ripening methods, including placebo. We employed ranking strategies to determine the most efficacious method using the surface under the cumulative ranking curve; a higher surface under the cumulative ranking curve value implied a more efficacious method. We assessed the following outcomes: time from intervention to delivery, cesarean delivery rates, changes in the Bishop score, need for additional ripening methods, incidence of Apgar scores <7 at 5 minutes, and uterine hyperstimulation. RESULTS: We included data from 42 randomized controlled trials including 6093 participants. When assessing the efficacy of all methods, 25 µg vaginal misoprostol was the most efficacious in reducing the time from intervention to delivery (surface under the cumulative ranking curve of 1.0) without increasing the odds of cesarean delivery, the need for additional ripening methods, the incidence of a low Apgar score, or uterine hyperstimulation. Acupressure (surface under the cumulative ranking curve of 0.3) and primrose oil (surface under the cumulative ranking curve of 0.2) were the least effective methods in reducing the time to delivery interval. Among effective methods, 50 mg oral mifepristone was associated with the lowest odds of cesarean delivery (surface under the cumulative ranking curve of 0.9). CONCLUSION: When balancing efficacy and safety, vaginal misoprostol 25 µg represents the best method for outpatient cervical ripening.


Subject(s)
Misoprostol , Oxytocics , Pregnancy , Female , Humans , Misoprostol/therapeutic use , Oxytocics/therapeutic use , Cervical Ripening , Network Meta-Analysis , Outpatients , Labor, Induced/methods
11.
Am J Obstet Gynecol ; 230(3S): S653-S661, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38462251

ABSTRACT

Childbirth is a defining moment in anyone's life, and it occurs 140 million times per year. Largely a physiologic process, parturition does come with risks; one mother dies every two minutes. These deaths occur mostly among healthy women, and many are considered preventable. For each death, 20 to 30 mothers experience complications that compromise their short- and long-term health. The risk of birth extends to the newborn, and, in 2020, 2.4 million neonates died, 25% in the first day of life. Hence, intrapartum care is an important priority for society. The American Journal of Obstetrics & Gynecology has devoted two special Supplements in 2023 and 2024 to the clinical aspects of labor at term. This article describes the content of the Supplements and highlights new developments in the induction of labor (a comparison of methods, definition of failed induction, new pharmacologic agents), management of the second stage, the value of intrapartum sonography, new concepts on soft tissue dystocia, optimal care during the third stage, and common complications that account for maternal death, such as infection, hemorrhage, and uterine rupture. All articles are available to subscribers and non-subscribers and have supporting video content to enhance dissemination and improve intrapartum care. Our hope is that no mother suffers because of lack of information.


Subject(s)
Labor, Obstetric , Uterine Rupture , Pregnancy , Infant, Newborn , Female , Humans , Uterine Rupture/etiology , Delivery, Obstetric , Labor, Induced/methods , Parturition
12.
Am J Obstet Gynecol ; 230(3S): S759-S768, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38462256

ABSTRACT

BACKGROUND: Slow progression of labor is a common obstetrical problem with multiple associated complications. Tafoxiparin is a depolymerized form of heparin with a molecular structure that eliminates the anticoagulant effects of heparin. We report on 2 phase II clinical studies of tafoxiparin in primiparas. Study 1 was an exploratory, first-in-pregnant-women study and study 2 was a dose-finding study. OBJECTIVE: Study 1 was performed to explore the effects on labor time of subcutaneous administration of tafoxiparin before onset of labor. Study 2 was performed to test the hypothesis that intravenous treatment with tafoxiparin reduces the risk for prolonged labor after spontaneous labor onset in situations requiring oxytocin stimulation because of dystocia. STUDY DESIGN: Both studies were randomized, double-blind, and placebo-controlled. Participants were healthy, nulliparous females aged 18 to 45 years with a normal singleton pregnancy and gestational age confirmed by ultrasound. The primary endpoints were time from onset of established labor (cervical dilation of 4 cm) until delivery (study 1) and time from start of study treatment infusion until delivery (study 2). In study 1, patients at 38 to 40 weeks of gestation received 60 mg tafoxiparin or placebo daily as 0.4 mL subcutaneous injections until labor onset (maximum 28 days). In study 2, patients experiencing slow progression of labor, a prolonged latent phase, or labor arrest received a placebo or 1 of 3 short-term tafoxiparin regimens (initial bolus 7, 21, or 35 mg followed by continuous infusion at 5, 15, or 25 mg/hour until delivery; maximum duration, 36 hours) in conjunction with oxytocin. RESULTS: The number of participants randomized in study 1 was 263, and 361 were randomized in study 2. There were no statistically significant differences in the primary endpoints between those receiving tafoxiparin and those receiving the placebo in both studies. However, in study 1, the risk for having a labor time exceeding 12 hours was significantly reduced by tafoxiparin (tafoxiparin 6/114 [5%] vs placebo 18/101 [18%]; P=.0045). Post hoc analyses showed that women who underwent labor induction had a median (range) labor time of 4.44 (1.2-8.5) hours with tafoxiparin and 7.03 (1.5-14.3) hours with the placebo (P=.0041) and that co-administration of tafoxiparin potentiates the effect of oxytocin and facilitates a shorter labor time among women with a labor time exceeding 6 to 8 hours (P=.016). Among women induced into labor, tafoxiparin had a positive effect on cervical ripening in 11 of 13 cases (85%) compared with 3 of 13 participants (23%) who received the placebo (P=.004). For women requiring oxytocin because of slow progression of labor, the corresponding results were 34 of 51 participants (66%) vs 16 of 40 participants (40%) (P=.004). In study 2, tafoxiparin had no positive effects on the secondary endpoints when compared with the placebo. Except for injection-site reactions in study 1, adverse events were no more common for tafoxiparin than for the placebo among either mothers or infants. There were few serious or treatment-related adverse events. CONCLUSION: Subcutaneous treatment with tafoxiparin before labor onset (study 1) may be effective in reducing the labor time among women undergoing labor induction and among those requiring oxytocin for slow progression of labor. Moreover, tafoxiparin may have a positive effect on cervical ripening. Short-term, intravenous treatment with tafoxiparin as an adjunct to oxytocin in patients with labor arrest (study 2) did not affect labor time or other endpoints. Both studies suggest that tafoxiparin has a favorable safety profile in mothers and their infants.


Subject(s)
Oxytocics , Pregnancy , Humans , Female , Oxytocin/therapeutic use , Pharmaceutical Preparations , Cervical Ripening , Labor, Induced/methods , Heparin , Randomized Controlled Trials as Topic
13.
Am J Obstet Gynecol ; 230(3S): S669-S695, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38462252

ABSTRACT

This review assessed the efficacy and safety of pharmacologic agents (prostaglandins, oxytocin, mifepristone, hyaluronidase, and nitric oxide donors) and mechanical methods (single- and double-balloon catheters, laminaria, membrane stripping, and amniotomy) and those generally considered under the rubric of complementary medicine (castor oil, nipple stimulation, sexual intercourse, herbal medicine, and acupuncture). A substantial body of published reports, including 2 large network meta-analyses, support the safety and efficacy of misoprostol (PGE1) when used for cervical ripening and labor induction. Misoprostol administered vaginally at doses of 50 µg has the highest probability of achieving vaginal delivery within 24 hours. Regardless of dosing, route, and schedule of administration, when used for cervical ripening and labor induction, prostaglandin E2 seems to have similar efficacy in decreasing cesarean delivery rates. Globally, although oxytocin represents the most widely used pharmacologic agent for labor induction, its effectiveness is highly dependent on parity and cervical status. Oxytocin is more effective than expectant management in inducing labor, and the efficacy of oxytocin is enhanced when combined with amniotomy. However, prostaglandins administered vaginally or intracervically are more effective in inducing labor than oxytocin. A single 200-mg oral tablet of mifepristone seems to represent the lowest effective dose for cervical ripening. The bulk of the literature assessing relaxin suggests this agent has limited benefit when used for this indication. Although intracervical injection of hyaluronidase may cause cervical ripening, the need for intracervical administration has limited the use of this agent. Concerning the vaginal administration of nitric oxide donors, including isosorbide mononitrate, isosorbide, nitroglycerin, and sodium nitroprusside, the higher incidence of side effects with these agents has limited their use. A synthetic hygroscopic cervical dilator has been found to be effective for preinduction cervical ripening. Although a pharmacologic agent may be administered after the use of the synthetic hygroscopic dilator, in an attempt to reduce the interval to vaginal delivery, concomitant use of mechanical and pharmacologic methods is being explored. Combining the use of a single-balloon catheter with dinoprostone, misoprostol, or oxytocin enhances the efficacy of these pharmacologic agents in cervical ripening and labor induction. The efficacy of single- and double-balloon catheters in cervical ripening and labor induction seems similar. To date, the combination of misoprostol with an intracervical catheter seems to be the best approach when balancing delivery times with safety. Although complementary methods are occasionally used by patients, given the lack of data documenting their efficacy and safety, these methods are rarely used in hospital settings.


Subject(s)
Abortifacient Agents, Nonsteroidal , Misoprostol , Oxytocics , Female , Humans , Pregnancy , Cervical Ripening , Dinoprostone , Hyaluronoglucosaminidase/adverse effects , Hyaluronoglucosaminidase/pharmacology , Labor, Induced/methods , Mifepristone , Nitric Oxide Donors/adverse effects , Nitric Oxide Donors/pharmacology , Oxytocin
14.
J Am Board Fam Med ; 37(1): 147-149, 2024 Mar 11.
Article in English | MEDLINE | ID: mdl-38448237

ABSTRACT

In pregnant patients at term undergoing induction of labor, early time-based artificial rupture of membranes (AROM) within 1 hour of Foley bulb expulsion results in a shorter duration of labor by nearly 9 hours with no significant difference in cesarean delivery rates or maternal or neonatal adverse outcomes.1.


Subject(s)
Amniotomy , Cervical Ripening , Pregnancy , Female , Infant, Newborn , Humans , Cesarean Section , Time Factors , Labor, Induced/methods
15.
Am J Obstet Gynecol MFM ; 6(4): 101325, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38447677

ABSTRACT

BACKGROUND: Vaginal examination to monitor labor progress is recommended at least every 4 hours, but it can cause pain and embarrassment to women. Trial data are limited on the best intensity for vaginal examination. Vaginal examination is not needed for oxytocin dose titration after an amniotomy has been performed and oxytocin infusion started. The Foley balloon commonly ripens the cervix without strong contractions. Amniotomy and oxytocin infusion are usually required to drive labor. OBJECTIVE: This study aimed to evaluate the first vaginal examination at 8 vs 4 hours after amniotomy-oxytocin after Foley ripening in multiparous labor induction. STUDY DESIGN: A randomized controlled trial was conducted from October 2021 to September 2022 at the University Malaya Medical Center, Kuala Lumpur, Malaysia. Multiparas at term were recruited at admission for labor induction. Participants were randomized to a first routine vaginal examination at 8 or 4 hours after Foley balloon ripening and amniotomy. Titrated oxytocin infusion was routinely commenced after amniotomy to initiate contractions. The 2 primary outcomes were the time from amniotomy to delivery (noninferiority hypothesis) and maternal satisfaction (superiority hypothesis). Data were analyzed using the Student t test, Mann-Whitney U test, and chi-square test (or Fisher exact test), as suitable for the data. RESULTS: A total of 204 women were randomized, 102 to each arm. Amniotomy to birth intervals were 4.97±2.47 hours in the 8-hour arm and 5.79±3.17 hours in the 4-hour arm (mean difference, -0.82; 97.5% confidence interval, -1.72 to 0.08; P=.041; Bonferroni correction), which were noninferior within the prespecified 2-hour upper margin, and the maternal satisfaction scores (11-point 0-10 numerical rating scale) with allocated labor care were 9 (interquartile range, 8-9) in the 8-hour arm and 8 (interquartile range, 7-9) in the 4-hour arm (P=.814). In addition, oxytocin infusion to birth interval difference was noninferior within the 97.5% confidence interval (-1.59 to 0.23) margin of 1.3 hours. Of the maternal outcomes, the amniotomy to first vaginal examination intervals were 3.9±1.8 hours in the 8-hour arm and 3.4±1.3 hours in the 4-hour arm (P=.026), and the numbers of vaginal examinations were 2.00 (interquartile range, 2.00-3.00) in the 8-hour arm and 3.00 (interquratile range, 2.00-3.25) in the 4-hour arm (P<.001). For the 8-hour arm, the first vaginal examination was less likely to be as scheduled and more likely to be indicated by sensation to bear down (P<.001), and the epidural analgesia rates were lower (13/102 participants [12.7%] in the 8-hour arm vs 28/102 participants [27.5%] in the 4-hour arm; relative risk, 0.46; 95% confidence interval, 0.26-0.84; P=.009). Other outcomes of the mode of delivery, indications for cesarean delivery, and delivery blood loss were not different. Neonatal outcomes were not different. CONCLUSION: Routine first vaginal examination at 8 hours compared with that at 4 hours was noninferior for the time to birth but did not improve maternal satisfaction.


Subject(s)
Amniotomy , Cervical Ripening , Labor, Induced , Oxytocics , Oxytocin , Humans , Female , Labor, Induced/methods , Pregnancy , Adult , Amniotomy/methods , Oxytocics/administration & dosage , Oxytocin/administration & dosage , Cervical Ripening/physiology , Cervical Ripening/drug effects , Malaysia , Time Factors , Parity , Patient Satisfaction
16.
Acta Obstet Gynecol Scand ; 103(7): 1254-1262, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38468190

ABSTRACT

INTRODUCTION: Labor is both a physiological and physical activity that requires energy expenditure by the woman. Despite this, women are often fasted in labor, with hydration requirements addressed predominantly by intravenous therapy. Little is known about how best to manage this in nulliparous women undergoing induction of labor, who can be prone to lengthy labors. Therefore, we undertook a systematic review and meta-analysis to determine the effects of intravenous hydration regimens on nulliparous women undergoing induction of labor. MATERIAL AND METHODS: A systematic review and meta-analysis were conducted. Databases searched were PubMed, CINAHL, Embase, Cochrane, Scopus, and Web of Science using the search strategy combination of associated key concepts for intravenous therapy and nulliparous laboring women. The primary outcome was excessive neonatal weight loss. Meta-analyses for categorical outcomes included estimates of odds ratio (OR) and their 95% confidence intervals (CI) calculated; and for continuous outcomes the standardized mean difference, each with its 95% CI. Heterogeneity was assessed visually and by using the χ2 statistic and I2 with significance being set at p < 0.10. RESULTS: A total of 1512 studies were located and following screening, three studies met the eligibility criteria. No studies reported excessive neonatal weight loss. Increased rates of intravenous therapy (250 mL/h vs. 125 mL/h) during labor were not found to reduce the overall length of labor (mean difference -0.07 h, 95% CI -0.27 to 0.13 h) or reduce cesarean sections (OR 0.74, 95% CI 0.45-1.23), when women were not routinely fasted. CONCLUSIONS: Our review found no significant improvements for nulliparous women who received higher intravenous fluid volumes when undergoing induction of labor and were not routinely fasted. However, data are limited, and further research is needed.


Subject(s)
Fluid Therapy , Labor, Induced , Parity , Humans , Female , Pregnancy , Labor, Induced/methods , Fluid Therapy/methods , Infusions, Intravenous
17.
J Gynecol Obstet Hum Reprod ; 53(5): 102770, 2024 May.
Article in English | MEDLINE | ID: mdl-38503382

ABSTRACT

OBJECTIVE: To compare Foley catheter insertion by digital blind method to its placement with a sterile speculum in women with unripe cervix for induction of labor. METHODS: A systematic search was conducted in Cochrane Library, PubMed, Web of Science, and Scopus databases for randomized clinical trials (RCTs) from inception to July 2023. Included studies compared digital to speculum placement of the Foley catheter for labor induction. Data from the included studies were extracted and pooled using RevMan software for meta-analysis. The primary outcome was pain score during the procedure measured by the Visual Analog Scale (VAS). Secondary outcomes included Foley catheter insertion duration, cesarean delivery rate, induction to delivery interval, Bishop score, need for other cervical ripening methods, maternal satisfaction, and maternal fever. RESULTS: Four RCTs involving a total of 600 patients met the inclusion criteria. Pain during the procedure and Foley catheter insertion duration were significantly reduced in the digital insertion group compared to the speculum-guided group (p < 0.05). The Bishop score showed a significant improvement in the digital Foley catheter placement group. However, there were no statistically significant differences in the cesarean delivery rate or the requirement for additional cervical ripening methods between the two groups. Maternal satisfaction with the delivery process was significantly improved in the digital insertion group (p < 0.001). Induction to delivery interval and maternal fever were comparable between both groups. CONCLUSIONS: Digital placement of Foley catheter can be considered as an alternative to the sterile speculum method for pre-induction cervical ripening. More trials are required to confirm our findings.


Subject(s)
Labor, Induced , Randomized Controlled Trials as Topic , Humans , Labor, Induced/methods , Labor, Induced/instrumentation , Female , Pregnancy , Cervical Ripening , Surgical Instruments , Cesarean Section/methods , Urinary Catheterization/methods , Urinary Catheterization/instrumentation
18.
Am J Obstet Gynecol MFM ; 6(4): 101349, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38490333

ABSTRACT

BACKGROUND: Foley catheter insertion is frequently used for cervical ripening during the induction of labor. However, the insertion failure, safety, maternal side effects, complications, and satisfaction of digital compared with speculum-guided Foley catheter placement have not been evaluated in a large trial involving primigravida. OBJECTIVE: The study aimed to compare the insertion failure rate of digital and speculum-based transcervical Foley catheter placement in primigravida. The co-primary outcome was insertion-associated pain. The secondary outcomes were the time required for successful insertion, maternal satisfaction, and maternal complications within 24 hours of Foley insertion. STUDY DESIGN: This randomized, open-label, parallel-arm, noninferiority clinical trial was performed in a large tertiary care university hospital. Primigravida aged >18 years with term gestation (≥37 weeks) were included in this study. Additional inclusion criteria for enrollment in this study were singleton pregnancy with a cephalic presentation, intact membrane, a Bishop score of ≤5, and reassuring preinduction fetal heart rate tracing. All women planned for cervical ripening were assessed for eligibility and were randomized into digital or speculum arms. Foley catheter insertion was performed in a supine lithotomy position. Vaginal and cervical cleaning were performed before insertion. A 22-French Foley balloon catheter was guided digitally or via speculum to position the bulb at the level of the internal os using water-soluble lubricant. Insertion-associated pain was measured using a visual numeric rating scale, and maternal satisfaction was assessed using a set of questions. RESULTS: Four hundred and sixty-nine pregnant women were assessed for eligibility, and 446 patients were enrolled and randomized. The median age of the parturients was 24 (19-40) and 24 (18-38) years, respectively. The body mass index, gestational age at randomization, the incidence of postdated pregnancy, and prerandomization Bishop scores were comparable. Insertion failure was observed in 24 (10.8%) and 17 (7.6%) women in digital and speculum arms, respectively (relative risk=1.41 [95% confidence interval, 0.78-2.55]; P=.25). Requirements of >1 attempt (5.4% vs 3.6%) followed by the change in hands (3.6% vs 2.7%) were the most common reasons for insertion failure. The median (interquartile range) visual numeric rating scale was comparable (6 [2-9] vs 5 [2-10]; P=.15). The time taken for successful insertion was similar (58 [12-241] vs 54 [10-281]; P=.30). 9.4% and 10.8% of women required additional methods of cervical ripening. More women in the speculum group (41.7% vs 33.2%; P=.06) felt a medium level of discomfort than the digital group. CONCLUSION: Insertion failure and insertion-related pain in the digital approach were comparable to the speculum-guided approach for transcervical Foley catheter insertion in primigravida for cervical ripening. Nevertheless, maternal satisfaction was higher in the digital group because of a lesser level of discomfort.


Subject(s)
Cervical Ripening , Gravidity , Labor, Induced , Humans , Female , Pregnancy , Cervical Ripening/physiology , Adult , Labor, Induced/methods , Labor, Induced/instrumentation , Urinary Catheterization/methods , Urinary Catheterization/instrumentation , Surgical Instruments , Patient Satisfaction , Young Adult
19.
Am J Obstet Gynecol MFM ; 6(5): 101354, 2024 May.
Article in English | MEDLINE | ID: mdl-38494155

ABSTRACT

OBJECTIVE: This study aimed to identify evidence-based peripartum interventions for people with a body mass index ≥40 kg/m2. DATA SOURCES: PubMed, MEDLINE, EMBASE, Cochrane, CINAHL, and ClinicalTrials.gov were searched from inception to 2022 without date, publication type, or language restrictions. STUDY ELIGIBILITY CRITERIA: Cohort and randomized controlled trials that implemented an intervention and evaluated peripartum outcomes of people with a body mass index ≥40 kg/m2 were included. The primary outcome depended on the intervention but was commonly related to wound morbidity after cesarean delivery (ie, infection, separation, hematoma). METHODS: Meta-analysis was completed for interventions with at least 2 studies. Pooled risk ratios with 95% confidence intervals and heterogeneity (I2 statistics) were reported. RESULTS: Of 20,301 studies screened, 30 studies (17 cohort and 13 randomized controlled trials) encompassing 10 types of interventions were included. The interventions included delivery planning (induction of labor, planned cesarean delivery), antibiotics during labor induction or for surgical prophylaxis, 6 types of cesarean delivery techniques, and anticoagulation dosing after a cesarean delivery. Planned cesarean delivery compared with planned vaginal delivery did not improve outcomes according to 3 cohort studies. One cohort study compared 3 g with 2 g of cephazolin prophylaxis for cesarean delivery and found no differences in surgical site infections. According to 3 cohort studies and 2 randomized controlled trials, there was no improvement in outcomes with a non-low transverse skin incision. Ten studies (4 cohort and 6 randomized controlled trials) met the inclusion criteria for the meta-analysis. Two randomized controlled trials compared subcuticular closure with suture vs staples after cesarean delivery and found no differences in wound morbidity within 6 weeks of cesarean delivery (n=422; risk ratio, 1.09; 95% confidence interval, 0.75-1.59; I2=9%). Prophylactic negative-pressure wound therapy was compared with standard dressing in 4 cohort and 4 randomized controlled trials, which found no differences in wound morbidity (cohort n=2200; risk ratio, 1.19; 95% confidence interval, 0.88-1.63; I2=66.1%) or surgical site infections (randomized controlled trial n=1262; risk ratio, 0.90; 95% confidence interval, 0.63-1.29; I2=0). CONCLUSION: Few studies address interventions in people with a body mass index ≥40 kg/m2, and most studies did not demonstrate a benefit. Either staples or suture are recommended for subcuticular closure, but available data do not support prophylactic negative-pressure wound therapy after cesarean delivery for people with a body mass index ≥40 kg/m2.


Subject(s)
Cesarean Section , Peripartum Period , Humans , Female , Pregnancy , Cesarean Section/methods , Cesarean Section/adverse effects , Cesarean Section/statistics & numerical data , Labor, Induced/methods , Labor, Induced/statistics & numerical data , Obesity, Morbid , Surgical Wound Infection/prevention & control , Surgical Wound Infection/epidemiology , Randomized Controlled Trials as Topic/methods , Anticoagulants/administration & dosage , Body Mass Index , Antibiotic Prophylaxis/methods , Pregnancy Complications/prevention & control , Delivery, Obstetric/methods , Delivery, Obstetric/statistics & numerical data
20.
Acta Obstet Gynecol Scand ; 103(6): 1101-1111, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38504457

ABSTRACT

INTRODUCTION: Labor induction rates have increased over the last decades, and in many high-income countries, more than one in four labors are induced. Outpatient management of labor induction has been suggested in low-risk pregnancies to improve women's birth experiences while also promoting a more efficient use of healthcare resources. The primary aim of this paper was to assess the proportion of women in a historical cohort that would have been eligible for outpatient labor induction with oral misoprostol. Second, we wanted to report safety outcomes and assess efficacy outcomes for mothers and infants in pregnancies that met the criteria for outpatient care. MATERIAL AND METHODS: Criteria for outpatient labor induction with oral misoprostol were applied to a historical cohort of women with induction of labor at two Norwegian tertiary hospitals in the period January 1, through July 31, 2021. The criteria included low-risk women with an unscarred uterus expecting a healthy, singleton baby in cephalic position at term. The primary outcome was the proportion of women eligible for outpatient labor induction. Secondary outcomes included reasons for ineligibility and, for eligible women, safety and efficacy outcomes. RESULTS: Overall, 29.7% of the 1320 women who underwent labor induction in a singleton term pregnancy met the criteria for outpatient labor induction. We identified two serious adverse events that potentially could have occurred outside the hospital if the women had received outpatient care. The mean duration from initiation of labor induction to administration of the last misoprostol was 22.4 h. One in 14 multiparous women gave birth within 3 h after the last misoprostol dose. CONCLUSIONS: In this historical cohort, three in ten women met the criteria for outpatient management of labor induction with oral misoprostol. Serious adverse events were rare. The average time span from the initiation of labor induction to the last misoprostol was nearly 24 h. This suggests a potential for low-risk women with an induced labor to spend a substantial period of time at home before labor onset. However, larger studies testing or evaluating labor induction with oral misoprostol as an outpatient procedure are needed to draw conclusions.


Subject(s)
Ambulatory Care , Labor, Induced , Misoprostol , Oxytocics , Humans , Labor, Induced/methods , Female , Pregnancy , Misoprostol/administration & dosage , Adult , Oxytocics/administration & dosage , Cohort Studies , Norway
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