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1.
Am J Obstet Gynecol MFM ; 6(4): 101325, 2024 Apr.
Article En | MEDLINE | ID: mdl-38447677

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.


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
2.
Am J Obstet Gynecol MFM ; 6(4): 101349, 2024 Apr.
Article En | MEDLINE | ID: mdl-38490333

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.


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
3.
Arch Gynecol Obstet ; 309(2): 533-540, 2024 02.
Article En | MEDLINE | ID: mdl-36801968

PURPOSE: The aim of this study was to comparatively assess the efficacy and safety of double balloon catheter (DBC) and dinoprostone as labor-inducing agents just for multipara at term. METHODS: A retrospective cohort study was conducted among multipara at term with a Bishop score < 6 who needed planned labor induction from January 1, 2020, to December 30, 2020 in Maternal and Child Health Hospital of Hubei province, Tongji Medical College, Huazhong University of Science and Technology. They were divided into DBC group and dinoprostone group, respectively. Baseline maternal data, maternal and neonatal outcomes were recorded for statistical analysis. Total vaginal delivery rate, rate of vaginal delivery within 24 h, rate of uterine hyperstimulation combined with abnormal fetal heart rate(FHR) were regarded as the primary outcome variables. The difference between groups was considered statistically significant when p value < 0.05. RESULTS: A total of 202 multiparas was included for analysis (95 women in DBC group vs 107 women in dinoprostone group). There were no significant differences in total vaginal delivery rate and rate of vaginal delivery within 24 h between groups. Uterine hyperstimulation combined with abnormal FHR occurred exclusively in dinoprostone group. CONCLUSION: DBC and dinoprostone seem to be equally effective, while, DBC seems to be safer than dinoprostone.


Dinoprostone , Oxytocics , Pregnancy , Infant, Newborn , Child , Female , Humans , Dinoprostone/adverse effects , Oxytocics/adverse effects , Retrospective Studies , Administration, Intravaginal , Labor, Induced , Urinary Catheters , Cervical Ripening/physiology
4.
PLoS One ; 17(1): e0262292, 2022.
Article En | MEDLINE | ID: mdl-35061804

BACKGROUND: The purposes of successful induction of labor (IOL) are to shorten the time for IOL to delivery, increase the vaginal delivery rate, and reduce the rate of maternal and neonatal morbidity. In cases of unfavorable cervix (Bishop score <6), cervical ripening is advised to improve vaginal delivery rate. It may be initiated by mechanical (double balloon catheter (DBC), synthetic osmotic dilator) or pharmacologic (prostaglandins) methods, and the problem is complex due to the multitude of cervical ripening methods. We are constantly looking for the optimal protocol of cervical ripening for each woman. The present study aims to elucidate whether cervical ripening method is associated with increase rate of vaginal delivery, good women's experience and unaltered long-term quality of life after cervical ripening at term regarding maternal and obstetric characteristics. METHODS AND DESIGN: The MATUCOL study is a monocentric, prospective, observational study of all consecutive women who required cervical ripening (Bishop score <6) using different methods (DBC, vaginal dinoprostone, oral misoprostol) with a live fetus at term (≥37 weeks) between January 2020 and August 2021. The outcomes will be mode of delivery, maternal and neonatal morbidity, discomfort/pain assessments during cervical ripening, women's experience and satisfaction, and the impact of cervical ripening on the health-related quality of life at 3 months. If it reports a significant efficacy/safety/perinatal morbidity/women's satisfaction/quality of life at 3 months post-delivery associated with a method of cervical ripening in a specific situation (gestational and/or fetal disease) using a multivariate analysis, its use should be reconsidered in clinical practice. DISCUSSION: This study will reveal that some cervical ripening methods will be more effectiveness, safe, with good women's experiences and QOL at 3 months compared to others regarding maternal and obstetric characteristics. TRIAL REGISTRATION: This study is being performed at La Roche sur Yon Hospital following registration as GNEDS on January 8, 2020.


Cervical Ripening/physiology , Labor, Induced/methods , Labor, Induced/psychology , Adult , Cervical Ripening/drug effects , Cervix Uteri/drug effects , Cervix Uteri/pathology , Delivery, Obstetric/methods , Delivery, Obstetric/mortality , Dinoprostone/administration & dosage , Dinoprostone/therapeutic use , Female , Humans , Misoprostol/administration & dosage , Misoprostol/therapeutic use , Pregnancy , Prospective Studies , Quality of Life/psychology , Treatment Outcome
5.
J Matern Fetal Neonatal Med ; 35(24): 4763-4767, 2022 Dec.
Article En | MEDLINE | ID: mdl-33517810

Purpose: The aim of our study was to identify maternal characteristics of women who are responsive to the second application of vaginal dinoprostone in a cohort of patients with a low Bishop Score. Secondarily, we compared the outcome of the patients' response to a single application to that of the women's response to a double application.Materials and methods: This was a retrospective observational cohort study. Patients undergoing preinduction of labor with dinoprostone 10mg controlled-release vaginal device were included.Results: Among 216 included patients, 192 women (88.9%) achieved a cervical ripening after a single application of dinoprostone, while 24 (11.1%) required a second application. Patients notresponding to the first application of dinoprostone had a significantly higher body mass index (27.4 ± 6.7 kg/m2 vs 24.9 ± 5.2 kg/m2; p < 0.05) and a significant increase in gestational weight gain (14 ± 5.2 kg vs 11.6 ± 6.1; p < 0.005). Double application of dinoprostone resulted in spontaneousdelivery in 58.4% of cases, but it was related to poorer neonatal outcome, compared to a single application.Conclusions: Obese women, not responding to the first application of dinoprostone could respond to the second application of this vaginal prostaglandin. However, data related to the use of a double application are still very limited to recommend its use as a standardized procedurefor not responsive patients.


Dinoprostone , Oxytocics , Administration, Intravaginal , Cervical Ripening/physiology , Cohort Studies , Female , Humans , Infant, Newborn , Labor, Induced , Oxytocics/therapeutic use , Pregnancy
6.
Arch Gynecol Obstet ; 305(1): 11-18, 2022 01.
Article En | MEDLINE | ID: mdl-33973051

OBJECTIVE: To evaluate the safety in the first 12 h, efficacy and maternal satisfaction of a double balloon catheter (DBC) with vaginal prostaglandin (PGE) for induction of labour (IOL). METHODS: We conducted a multicentre randomised controlled study of 420 patients from 1st January 2016 to 31st December 2017 to evaluate the use of DBC in IOL in an Asian population looking at the adverse effects in the first 12 h after insertion. Women were assigned randomly to cervical ripening with either a DBC or a prostaglandin pessary. The adverse events in the 12 h after DBC or first prostaglandin inserted, the efficacy of a DBC to a prostaglandin in labour induction and maternal satisfaction were evaluated. RESULTS: There were significantly less women with uterine hyperstimulation in the DBC (2 vs 24, p ≤ 0.0001) compared to the prostaglandin group. There were no women with uterine hyperstimulation and non-reassuring foetal status in the DBC while there were 5 women with uterine hyperstimulation and foetal distress in the prostaglandin group. Use of entonox was significantly less in the DBC group (p = 0.009). There were no significant differences in both groups in caesarean section, vaginal deliveries and time to delivery, although significant less time was needed to achieve cervical os dilation more than 4 cm in the DBC group (p ≤ 0.0001). Neonatal birth outcomes were similar. Women's pain scores were similar for both methods. 80.1% of women allocated the DBC and 76.8% of women allocated the PGE were keen to recommend their method of induction. CONCLUSION: Double balloon catheter remains a good alternative method for inducing women in view of a good safety profile with low risk of hyperstimulation and high maternal satisfaction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02620215.


Oxytocics , Cervical Ripening/physiology , Cesarean Section/methods , Female , Humans , Infant, Newborn , Labor, Induced/methods , Oxytocics/adverse effects , Personal Satisfaction , Pessaries/adverse effects , Pregnancy , Prostaglandins , Urinary Catheters
7.
Biol Reprod ; 106(1): 173-184, 2022 01 13.
Article En | MEDLINE | ID: mdl-34664639

Despite aquaporin water channels (AQPs) play a critical role in maintaining water homeostasis in female reproductive tract and prompt a gradual increase in water content in cervical edema as pregnancy progressed, their relationship with macrophage infiltration and collagen content in human cervical remodeling need to be further investigated. This is the first study to examine the expression and localization of AQP3, AQP4, AQP5, AQP8, and macrophages simultaneously in human cervical ripening. The immunoreactivity of these AQPs was 2.6 to 6-fold higher on gestational weeks 26 (GD26W) than that on GD6W and GD15W, but AQP4 expression on GD39W dropped a similar extent on GD15W, other AQPs continued to rise on GD39W. The AQP3, AQP4, and AQP5 intensity seemed more abundant in cervical stroma than in the perivascular area on GD26W; the distribution of AQP3, AQP5, and AQP8 in cervical stroma was equivalent to that in the perivascular area on GD39W. Macrophage numbers were 1.7-fold higher in subepithelium region and 3.0-fold higher in center area on GD26W than that on GD15W; such numbers remained elevated on GD39W. The electron micrographs showed that cervical extensibility increased significantly on GD26W and GD39W accompanied with increased macrophage infiltration, cervical water content, and much more space among collagen fibers. These findings suggest that the upregulation of AQPs expression in human cervix is closely related to enhanced macrophage infiltration during pregnancy; there may be a positive feedback mechanism between them to lead the increase of water content and the degradation of collagen.


Aquaporins/analysis , Cervix Uteri/physiology , Macrophages/physiology , Adolescent , Adult , Aquaporin 3/analysis , Aquaporin 4/analysis , Aquaporin 5/analysis , Aquaporins/physiology , Cell Count , Cervical Ripening/physiology , Cervix Uteri/chemistry , Cervix Uteri/cytology , Collagen/analysis , Collagen/metabolism , Female , Gestational Age , Humans , Macrophages/ultrastructure , Microscopy, Electron , Pregnancy , Young Adult
8.
J Obstet Gynaecol ; 42(5): 883-887, 2022 Jul.
Article En | MEDLINE | ID: mdl-34565272

We investigated which treatment should be applied if primary cervical ripening with a dinoprostone pessary is unsuccessful. We included 281 women who experienced unsuccessful cervical ripening with a dinoprostone pessary and continued on induction of labour (IOL). Of the 281 women recruited, 177 were given a second dose of dinoprostone; 104 women received a balloon catheter. The second dinoprostone pessary was successful in achieving vaginal delivery in 88 of the 177 (48.6%) women, while the balloon catheter was successful in 42 of the 104 women (40.4%); there was no significant difference between the two treatments with regards to successful vaginal delivery. However, of the women who experienced successful vaginal delivery, the delivery rate in the dinoprostone group was significantly higher than that in the balloon catheter group 12, 24, 36, or 48 h after insertion (p = .0094, .0005, .0258, .0483, respectively). The neonatal outcomes, the proportion of maternal infection and postpartum haemorrhage were similar between the two groups.IMPACT STATEMENTWhat is already known on this subject? Labour induction is a common procedure in obstetrics in a bid to achieve vaginal delivery in China, because vaginal delivery is more beneficial and associated with a better quality of life as compared to a Caesarean delivery. There is consensus relating to the preferred method of IOL after unsuccessful IOL with a dinoprostone pessary.What do the results of this study add? This is the first study in a Chinese population to compare the dinoprostone pessary and balloon catheter for women with no response to dinoprostone for cervical ripening with a sample size greater than 100. We found that a second dose of dinoprostone can reduce the time from the re-initiation of IOL to vaginal delivery compared with the balloon catheter. Our data also indicated that all other outcomes relating to the mother and infant were similar.What are the implications of these findings for clinical practice and/or future research? A second dose of dinoprostone is a superior choice for women who experience unsuccessful IOL with dinoprostone to further accelerate vaginal delivery.


Dinoprostone , Oxytocics , Administration, Intravaginal , Catheters , Cervical Ripening/physiology , Female , Humans , Infant, Newborn , Labor, Induced/methods , Male , Pessaries , Pregnancy , Quality of Life
9.
J Gynecol Obstet Hum Reprod ; 51(1): 102235, 2022 Jan.
Article En | MEDLINE | ID: mdl-34583026

AIM: To conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) that examined the maternal and neonatal outcomes of misoprostol+isosorbide mononitrate (ISMN) versus misoprostol alone (control) in promoting cervical ripening during labor induction. METHODS: We searched five databases from inception until 05-May-2021. We assessed risk of bias of RCTs, meta-analyzed 23 endpoints, and pooled them as mean difference or risk ratio with 95% confidence interval. RESULTS: Overall, five RCTs met the inclusion criteria, comprising 850 patients (426 and 424 patients were allocated to misoprostol+ISMN and misoprostol group, respectively). Overall, the RCTs had a low risk of bias. Pertaining to maternal delivery-related outcomes, there was no significant difference between both groups regarding the mean interval from drug administration to delivery, rate of vaginal delivery, rate of cesarean section delivery, and rate of need for oxytocin augmentation. Pertaining to maternal drug-related side effects, the rate of maternal headache was significantly higher in disfavor of the misoprostol+ISMN compared with misoprostol alone. However, the rates of maternal nausea, hypotension, flushing, palpitation, dizziness, postpartum hemorrhage, and uterine tachysystole did not differ between both groups. Pertaining to neonatal outcomes, there was no significant difference between both groups regarding rates of NICU admission, meconium-stained amniotic fluid, and Apgar score <7 at five minutes. CONCLUSION: Compared with misoprostol alone, co-administration of misoprostol+ISMN did not correlate with superior maternal delivery-related outcomes. The rate of maternal headache was significantly higher in disfavor of the misoprostol+ISMN group. There was no significant difference between both groups regarding neonatal endpoints.


Cervical Ripening/drug effects , Isosorbide/pharmacology , Misoprostol/pharmacology , Adult , Cervical Ripening/physiology , Female , Humans , Isosorbide/therapeutic use , Labor, Induced/instrumentation , Labor, Induced/methods , Misoprostol/therapeutic use , Pregnancy , Randomized Controlled Trials as Topic/statistics & numerical data
10.
PLoS Med ; 18(2): e1003448, 2021 02.
Article En | MEDLINE | ID: mdl-33571294

BACKGROUND: Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2). METHODS AND FINDINGS: This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, ≥41+0 and ≤42+0 weeks' gestation, a Bishop score <6, intact membranes, and no history of cesarean delivery for whom induction of labour was decided were randomised to either mechanical cervical ripening with a Cook Cervical Ripening Balloon or pharmacological cervical ripening by a Propess vaginal pessary serving as a prostaglandin E2 slow-release system. The primary outcome was the rate of cesarean for nonreassuring fetal status, with an independent endpoint adjudication committee determining whether the fetal heart rate was nonreassuring. Secondary outcomes included delivery (time from cervical ripening to delivery, number of patients requiring analgesics), maternal and neonatal outcomes. Between January 2017 and December 2018, 1,220 women were randomised in a 1:1 ratio, 610 allocated to a silicone double balloon catheter, and 610 to the Propess vaginal pessary for the slow release of dinoprostone. The mean age of women was 31 years old, and 80% of them were of white ethnicity. The cesarean rates for nonreassuring fetal status were 5.8% (35/607) in the mechanical ripening group and 5.3% (32/609) in the pharmacological ripening group (proportion difference: 0.5%; 95% confidence interval (CI) -2.1% to 3.1%, p = 0.70). Time from cervical ripening to delivery was shorter in the pharmacological ripening group (23 hours versus 32 hours, median difference 6.5 95% CI 5.0 to 7.9, p < 0.001), and fewer women required analgesics in the mechanical ripening group (27.5% versus 35.4%, difference in proportion -7.9%, 95% CI -13.2% to -2.7%, p = 0.003). There were no statistically significant differences between the 2 groups for other delivery, maternal, and neonatal outcomes. A limitation was a low observed rate of cesarean section. CONCLUSIONS: In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone. TRIAL REGISTRATION: ClinicalTrials.gov NCT02907060.


Cervical Ripening/drug effects , Dinoprostone/pharmacology , Oxytocics/pharmacology , Silicones/pharmacology , Adult , Cervical Ripening/physiology , Cesarean Section/methods , Delivery, Obstetric/methods , Dinoprostone/administration & dosage , Female , Humans , Labor, Induced/methods , Oxytocics/administration & dosage , Pessaries , Pregnancy , Pregnancy, Prolonged/drug therapy
11.
BMC Pregnancy Childbirth ; 21(1): 17, 2021 Jan 06.
Article En | MEDLINE | ID: mdl-33407258

BACKGROUND: This study aims to evaluate the efficacy and safety of the induction of labour in mid-trimester pregnancy using a double-balloon catheter (DBC) within 12 h versus within 12-24 h. METHODS: In this retrospective study, a total of 58 pregnant women at 14 + 0 weeks to 27 + 6 weeks of gestation were enrolled as research subjects, and they underwent the intended termination of pregnancy at our birth centre from January 1, 2017, to June 31, 2019. Based on the duration of DBC, the patients were divided into two groups, namely, the DBC group within 12 h and the DBC group within 12-24 h. RESULTS: All 58 cases were successful vaginal deliveries, and no one chose to undergo caesarean section. The success rate of induction (successful abortion of the foetus and placenta without the implementation of dilation and evacuation) was higher in the DBC group within 12-24 h (96.3%, 29/31) than in the DBC group within 12 h (71.0%, 18/27) (p < 0.05). Additionally, the time from DBC removal to delivery in the DBC group within 12-24 h was significantly shorter than that in the DBC group within 12 h (3.0 h versus 17.8 h) (p < 0.05), and the degree of cervical dilation after DBC removal in the DBC group within 12-24 h was larger than that in the DBC group within 12 h (p < 0.05). CONCLUSION: In the clinic, the placement time of DBC generally lasts for approximately 12 h. However, considering that the cervical condition is immature in the mid-trimester, properly extending the placement time of DBC to 24 h will benefit cervical ripening and reduce the chance of dilation and evacuation.


Catheterization/methods , Gestational Age , Labor, Induced/methods , Abortion, Induced/methods , Adult , Catheterization/instrumentation , Cervical Ripening/physiology , Chromosome Aberrations , Delivery, Obstetric/methods , Female , Fetus/abnormalities , Humans , Labor Stage, First/physiology , Pregnancy , Pregnancy Trimester, Second , Retrospective Studies , Time Factors
12.
Nurs Womens Health ; 24(4): S1-S41, 2020 Aug.
Article En | MEDLINE | ID: mdl-32778395

Cervical ripening and induction and augmentation of labor are common procedures in labor and birth units. The potential risks and benefits for the procedure should be explained to women so that they can make informed decisions. Clinicians should be knowledgeable about the methods and medications used and be skilled in maternal-fetal assessment. Adequate nurse staffing is required to monitor the mother and fetus to promote the best possible outcomes. This practice monograph includes information on mechanical and pharmacologic methods for cervical ripening; labor induction and augmentation with oxytocin, a high alert drug; and nurse staffing levels and skills needed to provide safe and effective care during cervical ripening and labor induction and augmentation.


Cervical Ripening/physiology , Labor, Induced/methods , Obstetric Labor Complications/therapy , Oxytocin/adverse effects , Female , Humans , Nurse's Role , Obstetric Labor Complications/drug therapy , Oxytocics/administration & dosage , Pregnancy , Pregnancy Outcome
13.
BMC Pregnancy Childbirth ; 20(1): 391, 2020 Jul 06.
Article En | MEDLINE | ID: mdl-32631265

BACKGROUND: The purpose of this study was to compare the reliability and reproducibility of the traditional qualitative method of assessing uterine cervical stiffness with those of a quantitative method using a novel device based on the aspiration technique. METHODS: Five silicone models of the uterine cervix were created and used to simulate different cervical stiffnesses throughout gestation. The stiffness of the five cervix models was assessed both by digital palpation (firm, medium and soft) and with the Pregnolia System. Five self-trained participants conducted the device-based assessment, whereas 63 obstetricians and midwives, trained in digital palpation, conducted the cervical palpation. RESULTS: The results of the two methods were analyzed in terms of inter-and intra-observer variability. For digital palpation, there was no common agreement on the assessment of the stiffness, except for the softest cervix. When assessing the same cervix model for a second time, 76% of the obstetricians and midwives disagreed with their previous assessment. In contrast, the maximum standard deviation for the device-based stiffness assessment for intra- and inter-observer variability was 3% and 3.4%, respectively. CONCLUSIONS: This study has shown that a device based on the aspiration technique provides obstetricians and midwives with a method for objectively and repeatably assess uterine cervical stiffness, which can eliminate the need to rely solely on a subjective interpretation, as is the case with digital palpation.


Cervical Ripening/physiology , Cervix Uteri/physiology , Palpation/methods , Suction/instrumentation , Female , Humans , Models, Anatomic , Observer Variation , Pregnancy , Reproducibility of Results
14.
Femina ; 48(7): 432-438, jul. 31, 2020. ilus, tab
Article Pt | LILACS | ID: biblio-1117445

O encurtamento do colo uterino é parte da via final comum da parturição seja a termo ou pré-termo. A identificação precoce do comprimento cervical encurtado ao ultrassom transvaginal no segundo trimestre gestacional pode atuar como preditor de risco de prematuridade. Desde a década de 1990, vários estudiosos dedicaram-se a estabelecer parâmetros de referência para as medidas de colo uterino entre 16 e 24 semanas e até hoje o limite mais consensualmente aceito é de 25 mm. Especialistas são favoráveis à triagem universal, mas diretrizes internacionais são controversas quanto à investigação em casos sem antecedente de parto pré-termo, além de diversos estudos apresentarem que há custo-efetividade no rastreamento universal. Neste artigo, discutimos criticamente os parâmetros apresentados por estudos históricos e balizadores de conduta, a custo-efetividade e os guidelines internacionais. Propomos ainda uma reflexão ao pré-natalista, sugerindo a individualização da conduta perante os dados de cada gestante específica.(AU)


Cervical shortening is the final path of parturition, regardless if it is term or preterm. Precocious identification of a shortened cervix by transvaginal ultrasound during the second gestational trimester can act as a risk predictor of prematurity. Since the 1990´s decade, numerous studies established reference ranges for cervical length measurement between 16 to 24 gestational weeks and the most accepted cutoff limit is 25 mm. Experts indicate universal screening, however international guidelines are controversial, even in cases without a history of preterm birth, furthermore, many studies demonstrated cost-effectiveness about the universal screening of cervical length in middle gestation. In this article we discuss historical reference ranges, cost- -effectiveness, and international guidelines. We propose critical thinking and suggest individualized management according to specific characteristics of each patient.(AU)


Humans , Female , Pregnancy , Uterine Cervical Incompetence/diagnostic imaging , Cervical Length Measurement/methods , Obstetric Labor, Premature/prevention & control , Databases, Bibliographic , Ultrasonography, Prenatal/methods , Risk Assessment , Pregnancy, High-Risk , Cervical Ripening/physiology
15.
J Gynecol Obstet Hum Reprod ; 49(8): 101823, 2020 Oct.
Article En | MEDLINE | ID: mdl-32492523

OBJECTIVE: To compare between outpatient and inpatient balloon catheter insertion for labor induction. METHODS: We searched in four different databases for the available trials during May 2020. We included randomized controlled trials (RCTs) that compared outpatient to inpatient balloon catheter for induction of labor. We extracted the available data from the included studies and pooled them in meta-analysis using RevMan software. The dichotomous data were pooled as risk ratio (RR) and the continuous data were pooled as mean difference (MD) with the corresponding 95% confidence intervals (CI).Our primary outcome was the rate of cesarean delivery. Our secondary outcomes were the length of hospital stay, Bishop score, and different adverse events including postpartum hemorrhage, Apgar score less than 7 at 5 minutes, and chorioamnionitis. RESULTS: Eight RCTs with a total number of 740patients were included. The cesarean delivery rate was significantly reduced among outpatient balloon catheter compared to inpatient balloon catheter (RR = 0.63, 95% CI [0.46, 0.86], p = 0.004). Outpatient balloon catheter was associated with shorter hospital stay duration in comparison with inpatient group (MD= -0.38, 95% CI [-0.61, -0.14], p = 0.002). Outpatient group was linked to a more favorable increase in Bishop score (MD = 0.88, 95% CI [0.78, 0.98], p>0.001). There were no significant differences between both groups regarding different adverse events. CONCLUSION: Outpatient balloon catheter priming is safe and effective in reducing cesarean delivery rates and shortening the length of hospital stay with a better Bishop score.


Catheterization/instrumentation , Catheterization/methods , Inpatients , Labor, Induced/methods , Outpatients , Adult , Cervical Ripening/physiology , Cesarean Section/statistics & numerical data , Chorioamnionitis/epidemiology , Female , Humans , Length of Stay/statistics & numerical data , Postpartum Hemorrhage/epidemiology , Pregnancy , Randomized Controlled Trials as Topic , Treatment Outcome
16.
Article En | MEDLINE | ID: mdl-32527660

This chapter aims to provide an evidence-based approach to cervical-ripening methods and induction of labor in high-, middle-, and low-income countries. We will review the epidemiology of induction and will also review pharmacological and mechanical methods of cervical-ripening as well as oxytocin for induction. Lastly, we will review current guidelines of when to determine an induction to be failed.


Cervical Ripening/drug effects , Labor, Induced , Oxytocics/pharmacology , Oxytocin/pharmacology , Cervical Ripening/physiology , Dinoprostone , Female , Humans , Oxytocics/administration & dosage , Oxytocin/administration & dosage , Pregnancy
17.
J Gynecol Obstet Hum Reprod ; 49(8): 101834, 2020 Oct.
Article En | MEDLINE | ID: mdl-32585393

INTRODUCTION: Term prelabor rupture of membranes (TPROM) occurs in approximately 8 % of pregnancies. This condition regularly requires medical intervention such as induction of labor. The actual data concerning cervical ripening in case of TPROM does not favor any of the available techniques. This is the first study comparing dinoprostone versus Foley catheter for cervical ripening in TPROM. MATERIALS AND METHODS: We conducted a retrospective before-after study. We enrolled all the patients with confirmed TPROM after 37 weeks of gestation (WG) who required cervical ripening. Women were included if they had a singleton fetus in cephalic presentation, with unfavorable cervix (Bishop ≤ 6). Patients were excluded if they had a previous uterine surgery, a multiple pregnancy, contraindication to vaginal delivery, spontaneous labor or favorable cervix (Bishop > 6). During the first period (2015), the protocol of cervical ripening involved dinoprostone (prostaglandins E2) by vaginal administration (vaginal gel or pessary). During the second period (2016-2017), the protocol of cervical ripening involved Foley catheter (FC). The primary outcome was the rate of cesarean section. RESULTS: Two hundred and thirty-eight patients were included for the analysis: 131 in the first period (dinoprostone group) and 107 in the second period (foley catheter group). There was no significant difference between the two groups regarding the mode of delivery (cesarean section: 206 % vs 13 %, p = 016). Concerning tolerance, the were no difference in the rates of postpartum hemorrhage, maternal per-partum fever and endometrisis. Neonatal outcomes were similar between the two groups. The induction to delivery interval was lower with dinoprostone (20,3 h versus 26,0 h, p = 0001). The mean duration of labor was also significantly different (6,9 h for dinoprostone group versus 8,7 h for FC group, p = 001). CONCLUSION: Cervical ripening in case of TPROM after 37 W G with Foley catheter seems to be a safe technique with similar outcomes to prostaglandins regarding the mode of delivery.


Cervical Ripening/physiology , Dinoprostone/administration & dosage , Fetal Membranes, Premature Rupture/therapy , Labor, Induced/methods , Term Birth , Urinary Catheterization , Administration, Intravaginal , Adult , Cesarean Section/statistics & numerical data , Delivery, Obstetric/methods , Female , Humans , Infant, Newborn , Pregnancy , Retrospective Studies
18.
J Gynecol Obstet Hum Reprod ; 49(8): 101745, 2020 Oct.
Article En | MEDLINE | ID: mdl-32422363

OBJECTIVE: To evaluate the use of the intracervical balloon compared with locally applied prostaglandins for cervical ripening for induction in patients with preterm premature rupture of membranes. METHODS: Monocentric, retrospective (from 2002 to 2017) observational cohort study of singleton pregnancies complicated by preterm premature rupture of membranes and induced between 34 and 37 weeks. The primary outcome measure was balloon catheter efficiency evaluated by Cesarean section rate. Secondary outcomes were : interval from induction to delivery, labor duration, oxytocin use, intrauterine infection rate, maternal complications (i.e., postpartum hemorrhage and endometritis), and neonatal complications. RESULTS: 60 patients had cervical ripening with prostaglandins alone and 58 had balloon catheter. Demographic characteristics were similar between the groups, except for induction term and neonatal weight. There was not a significant difference in occurrence of Cesarean section rate (p = 0.14). Nor were there significant differences in time from induction to birth (p = 0.32) or in intrauterine infection rate (p = 0.95). Labor duration was shorter (p = 0.006) and total oxytocin dose lower (p = 0.005) in patients induced by prostaglandins alone. Concerning neonatal outcomes, there were more transfers to intensive care (p = 0.008) and more respiratory distress (p = 0.005) among newborns induced by prostaglandins. CONCLUSION: Compared with locally applied prostaglandins, balloon catheter induction is not associated with an increase of Cesarean section rate in patients with preterm premature rupture of membranes.


Cervical Ripening/physiology , Fetal Membranes, Premature Rupture , Labor, Induced/instrumentation , Labor, Induced/methods , Adult , Catheterization/instrumentation , Catheterization/methods , Cesarean Section/statistics & numerical data , Cohort Studies , Female , Gestational Age , Humans , Infant, Newborn , Labor, Induced/adverse effects , Oxytocin/administration & dosage , Pregnancy , Prostaglandins/administration & dosage , Prostaglandins/adverse effects , Reproductive Tract Infections/epidemiology , Retrospective Studies , Uterine Diseases/microbiology
19.
J Gynecol Obstet Hum Reprod ; 49(6): 101739, 2020 Jun.
Article En | MEDLINE | ID: mdl-32251738

OBJECTIVE: This study aims to evaluate the consequences of a trigger by vaginal Dinoprotone on outcome of pregnancies with Intrauterine growth restriction (IUGR). MATERIALS AND METHODS: This retrospective study included 161 induced IUGR fetuses (35-39 weeks). Consecutive patients who were evaluated formed the basis of the clinical outcomes. The penalized maximum likelihood estimation (PMLE) method was used instead of traditional logistic regression in order to reduce the risk of overfitting. RESULTS: Of the 25,678 deliveries that occurred during the study period, 161 (0.6%) women underwent IUGR delivery; of these, 117 (73%) succeeded and 44 (27%) failed to achieve cervical ripening using the dinoprostone slow-release vaginal insert. Two predictors were associated with dinoprostone vaginal delivery success: Parity (OR:1.4([0.89-2.3]), and Bishop score (OR:1.54[1.23-1.94]). The PMLE model correctly classified 78% participants (c-index: 0.78). CONCLUSION: Basic parameters such as parity and Bishop score can be used to predict successful vaginal birth following dinoprostone slow-release vaginal insert administration.


Cervical Ripening/drug effects , Dinoprostone/administration & dosage , Fetal Growth Retardation/therapy , Labor, Induced/methods , Administration, Intravaginal , Adolescent , Adult , Cervical Ripening/physiology , Cesarean Section/statistics & numerical data , Delayed-Action Preparations , Delivery, Obstetric/methods , Female , Gestational Age , Humans , Infant, Newborn , Pregnancy , Treatment Outcome , Young Adult
20.
Arch Gynecol Obstet ; 301(4): 931-940, 2020 04.
Article En | MEDLINE | ID: mdl-32140810

PURPOSE: To compare the effectiveness of cervical ripening by a mechanical method (double-balloon catheter) and a pharmacological method (prostaglandins) in women with one previous cesarean delivery, an unfavorable cervix (Bishop score < 6), and a singleton fetus in cephalic presentation. METHODS: This retrospective study, reviewing the relevant records for the years 2013 through 2017, took place in two French university hospital maternity units. This study included women with one previous cesarean delivery, a liveborn singleton fetus in cephalic presentation, and intact membranes, for whom cervical ripening, with unfavorable cervix (Bishop score < 6) was indicated for medical reasons. It compared two groups: (1) women giving birth in a hospital that uses a protocol for mechanical cervical ripening by a double-balloon catheter (DBC), and (2) women giving birth in a hospital that performed pharmacological cervical ripening by prostaglandins. The principal endpoint was the cesarean delivery rate. The secondary outcome measures were maternal and neonatal outcomes. RESULTS: We compared 127 women with prostaglandin ripening to 117 women with DBC. There was no significant difference between the two groups for the cesarean rate (42.5% in the prostaglandin group and 42.7% in the DBC group; p = 0.973; crude OR 1.01 [0.61-1.68]; adjusted OR 1.55 [0.71-3.37]). The median interval between the start of ripening and delivery did not differ between the groups (28.7 h in the prostaglandin group vs 25.6 h in the DBC group; p = 0.880). Neonatal outcomes did not differ between the groups, either. There was one case of uterine rupture in the prostaglandin group, with no associated maternal or neonatal morbidity. There were no neonatal deaths. The postpartum hemorrhage rate was significantly higher in the DBC group. CONCLUSION: For cervical ripening for women with one previous cesarean, the choice of a pharmacological or mechanical protocol does not appear to modify the mode of delivery or maternal or neonatal morbidity.


Catheterization/methods , Cervical Ripening/physiology , Cesarean Section/methods , Labor, Induced/methods , Prostaglandins/metabolism , Adult , Female , Humans , Pregnancy , Retrospective Studies
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