Methods of induction of labor in women with obesity : A secondary analysis of two multicenter randomized controlled trials

No funding was received for the original PROBAAT-I trial or this follow-up study. The original PROBAAT-II trial was funded by Fonds NutsOhra. MV received a doctoral grant for teachers from the Netherlands Organization for Scientific Research (023.011.051). BM is supported by a NHMRC Practitioner Fellowship (GNT1082548).Peer reviewe

Evaluation of treatment, prognostic factors, and survival in 198 vulvar melanoma patients: Implications for clinical practice

Objective: To identify clinicopathological characteristics, treatment patterns, clinical outcomes and prognostic factors in patients with vulvar melanoma (VM). Materials & methods: This retrospective multicentre cohort st

Induction of labor with Foley catheter and risk of subsequent preterm birth: follow-up study of two randomized controlled trials (PROBAAT-1 and -2)

Objective: To evaluate the rate of preterm birth (PTB) in a subsequent pregnancy in women who had undergone term induction using a Foley catheter compared with prostaglandins. Methods: This was a follow-up study of two large randomized controlled trials (PROBAAT-1 and PROBAAT-2). In the original trials, women with a term singleton pregnancy with the fetus in cephalic presentation and with an indication for labor induction were randomized to receive either a 30-mL Foley catheter or prostaglandins (vaginal prostaglandin E2 in PROBAAT-1 and oral misoprostol in PROBAAT-2). Data on subsequent ongoing pregnancies > 16 weeks’ gestation were collected from hospital charts from clinics participating in this follow-up study. The main outcome measure was preterm birth 16 weeks' gestation in the Foley catheter and prostaglandin groups, respectively. There were no differences in baseline characteristics between the groups. The overall rate of PTB in a subsequent pregnancy was 9/251 (3.6%) in the Foley catheter group vs 10/258 (3.9%) in the prostaglandin group (relative risk (RR), 0.93; 95% CI, 0.38–2.24), and the rate of spontaneous PTB was 5/251 (2.0%) vs 5/258 (1.9%) (RR, 1.03; 95% CI, 0.30–3.51). Conclusion: In women with term singleton pregnancy, induction of labor using a 30-mL Foley catheter is not associated with an increased risk of PTB in a subsequent pregnancy, as compared to induction of labor using prostaglandins

Does the New FIGO 2018 Staging System Allow Better Prognostic Differentiation in Early Stage Cervical Cancer? A Dutch Nationwide Cohort Study

The FIGO 2018 staging system was introduced to allow better prognostic differentiation in cervical cancer, causing considerable stage migration and affecting treatment options. We evaluated the accuracy of the FIGO 2018 staging in predicting recurrence free (RFS) and overall survival (OS) compared to FIGO 2009 staging in clinically early stage cervical cancer. We conducted a nationwide retrospective cohort study, including 2264 patients with preoperative FIGO (2009) IA1, IA2 and IB1 cervical cancer between 2007–2017. Kaplan–Meier analyses were used to assess survival outcomes. Logistic regression was used to assess risk factors for lymph node metastasis and parametrial invasion. Stage migration occurred in 48% (22% down-staged, 26% up-staged). Survival data of patients down-staged from IB to IA1/2 disease were comparable with FIGO 2009 IA1/2 and better than patients remaining stage IB1. LVSI, invasion depth and parametrial invasion were risk factors for lymph node metastases. LVSI, grade and age were associated with parametrial invasion. In conclusion, the FIGO 2018 staging system accurately reflects prognosis in early stage cervical cancer and is therefore more suitable than the FIGO 2009 staging. However subdivision in IA1 or IA2 based on presence or absence of LVSI instead of depth of invasion would have improved accuracy. For patients down-staged to IA1/2, less radical surgery seems appropriate, although LVSI and histology should be considered when determining the treatment plan

Progress of labor in women induced with misoprostol vs the Foley catheter

Research into fetal development and medicin

Induction of Labor Using a Foley Catheter or Misoprostol : A Systematic Review and Meta-analysis

Importance: Induction of labor is a widely used obstetric intervention, occurring in one in four pregnancies. When the cervix is unfavorable, still many different induction methods are used. Objective: We compared Foley catheter alone to different misoprostol dosages and administration routes, and the combination of Foley catheter with misoprostol. Evidence acquisition: We reviewed the literature on the best induction method regarding their safety and effectiveness, using the outcome measures hyperstimulation, fetal distress, neonatal morbidity and mortality as well as cesarean delivery, vaginal instrumental delivery, and maternal morbidity. We searched Pubmed, Cochrane, and Web of Science from January 1, 1980 to February 12, 2016. Twenty-two randomized controlled trials (RCTs) were included, comparing Foley catheter with or without misoprostol to misoprostol alone (both vaginal and oral) for induction of labor (5,015 women). Results: Most included studies were underpowered to detect differences in safety outcomes, as the majority are powered for time to delivery or cesarean delivery. Meta-analysis of these studies does not allow assessment of the safety profile of Foley catheter compared to misoprostol (any dose, any administration route) with sufficient power. For the safety outcomes of the total group of Foley catheter versus misoprostol (any dose, any administration route) (17 studies, 4,234 women) we found that Foley catheter results in less hyperstimulation compared to misoprostol (2% versus 4%; risk ratio [RR], 0.54; 95% confidence interval [CI], 0.37-0.79) and fewer cesarean deliveries for nonreassuring fetal heart rate, 5% vs 7%; RR, 0.72; 95% CI, 0.55-0.95; while there were no statistically significant differences in neonatal outcomes. The total number of cesarean deliveries was 26% versus 22% (RR, 1.16; 95% CI, 1.00-1.34). There were fewer vaginal instrumental deliveries with a Foley catheter compared to misoprostol (10% vs 14%; RR, 0.74; 95% CI, 0.60-0.91). Foley catheter with misoprostol compared to misoprostol alone (any dose, any administration route) (7 studies, 1,073 women) resulted in less hyperstimulation than misoprostol alone (17% vs 23%; RR, 0.71; 95% CI, 0.52-0.97). Cesarean deliveries for nonreassuring fetal heart rate were comparable (7% vs 9%; RR, 0.79; 95% CI, 0.51-1.22). Neonatal outcomes were infrequently reported. The total number of cesarean deliveries was 34% versus 34% (RR, 1.01; 95% CI, 0.86-1.19). Conclusion: In women with an unripe cervix at term, Foley catheter seems to have a better safety profile than misoprostol (any dose, any administration route) for induction of labor. Larger studies are needed to investigate the safety profile of a Foley catheter compared to separate dosing and administration regimens of misoprostol

Induction of Labor Using a Foley Catheter or Misoprostol : A Systematic Review and Meta-analysis

Importance: Induction of labor is a widely used obstetric intervention, occurring in one in four pregnancies. When the cervix is unfavorable, still many different induction methods are used. Objective: We compared Foley catheter alone to different misoprostol dosages and administration routes, and the combination of Foley catheter with misoprostol. Evidence acquisition: We reviewed the literature on the best induction method regarding their safety and effectiveness, using the outcome measures hyperstimulation, fetal distress, neonatal morbidity and mortality as well as cesarean delivery, vaginal instrumental delivery, and maternal morbidity. We searched Pubmed, Cochrane, and Web of Science from January 1, 1980 to February 12, 2016. Twenty-two randomized controlled trials (RCTs) were included, comparing Foley catheter with or without misoprostol to misoprostol alone (both vaginal and oral) for induction of labor (5,015 women). Results: Most included studies were underpowered to detect differences in safety outcomes, as the majority are powered for time to delivery or cesarean delivery. Meta-analysis of these studies does not allow assessment of the safety profile of Foley catheter compared to misoprostol (any dose, any administration route) with sufficient power. For the safety outcomes of the total group of Foley catheter versus misoprostol (any dose, any administration route) (17 studies, 4,234 women) we found that Foley catheter results in less hyperstimulation compared to misoprostol (2% versus 4%; risk ratio [RR], 0.54; 95% confidence interval [CI], 0.37-0.79) and fewer cesarean deliveries for nonreassuring fetal heart rate, 5% vs 7%; RR, 0.72; 95% CI, 0.55-0.95; while there were no statistically significant differences in neonatal outcomes. The total number of cesarean deliveries was 26% versus 22% (RR, 1.16; 95% CI, 1.00-1.34). There were fewer vaginal instrumental deliveries with a Foley catheter compared to misoprostol (10% vs 14%; RR, 0.74; 95% CI, 0.60-0.91). Foley catheter with misoprostol compared to misoprostol alone (any dose, any administration route) (7 studies, 1,073 women) resulted in less hyperstimulation than misoprostol alone (17% vs 23%; RR, 0.71; 95% CI, 0.52-0.97). Cesarean deliveries for nonreassuring fetal heart rate were comparable (7% vs 9%; RR, 0.79; 95% CI, 0.51-1.22). Neonatal outcomes were infrequently reported. The total number of cesarean deliveries was 34% versus 34% (RR, 1.01; 95% CI, 0.86-1.19). Conclusion: In women with an unripe cervix at term, Foley catheter seems to have a better safety profile than misoprostol (any dose, any administration route) for induction of labor. Larger studies are needed to investigate the safety profile of a Foley catheter compared to separate dosing and administration regimens of misoprostol

Mechanical methods for induction of labour

BACKGROUND: Mechanical methods were the first methods developed to ripen the cervix and induce labour. During recent decades they have been substituted by pharmacological methods. Potential advantages of mechanical methods, compared with pharmacological methods may include reduction in side effects that could improve neonatal outcomes. This is an update of a review first published in 2001, last updated in 2012. OBJECTIVES: To determine the effectiveness and safety of mechanical methods for third trimester (> 24 weeks' gestation) induction of labour in comparison with prostaglandin E2 (PGE2) (vaginal and intracervical), low-dose misoprostol (oral and vaginal), amniotomy or oxytocin. SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), and reference lists of retrieved studies (9 January 2018). We updated the search in March 2019 and added the search results to the awaiting classification section of the review. SELECTION CRITERIA: Clinical trials comparing mechanical methods used for third trimester cervical ripening or labour induction with pharmacological methods.Mechanical methods include: (1) the introduction of a catheter through the cervix into the extra-amniotic space with balloon insufflation; (2) introduction of laminaria tents, or their synthetic equivalent (Dilapan), into the cervical canal; (3) use of a catheter to inject fluid into the extra-amniotic space (EASI).This review includes the following comparisons: (1) specific mechanical methods (balloon catheter, laminaria tents or EASI) compared with prostaglandins (different types, different routes) or with oxytocin; (2) single balloon compared to a double balloon; (3) addition of prostaglandins or oxytocin to mechanical methods compared with prostaglandins or oxytocin alone. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and assessed risk of bias. Two review authors independently extracted data and assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: This review update includes a total of 113 trials (22,373 women) contributing data to 21 comparisons. Risk of bias of trials varied. Overall, the evidence was graded from very-low to moderate quality. All evidence was downgraded for lack of blinding and, for many comparisons, the effect estimates were too imprecise to make a valid judgement.Balloon versus vaginal PGE2: there may be little or no difference in vaginal deliveries not achieved within 24 hours (average risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.26; 7 studies; 1685 women; I² = 79%; low-quality evidence) and there probably is little or no difference in caesarean sections (RR 1.00, 95% CI 0.92 to 1.09; 28 studies; 6619 women; moderate-quality evidence) between induction of labour with a balloon catheter and vaginal PGE2. A balloon catheter probably reduces the risk of uterine hyperstimulation with fetal heart rate (FHR) changes (RR 0.35, 95% CI 0.18 to 0.67; 6 studies; 1966 women; moderate-quality evidence), serious neonatal morbidity or perinatal death (RR 0.48, 95% CI 0.25 to 0.93; 8 studies; 2757 women; moderate-quality evidence) and may slightly reduce the risk of aneonatal intensive care unit (NICU) admission (RR 0.82, 95% CI 0.65 to 1.04; 3647 women; 12 studies; low-quality evidence). It is uncertain whether there is a difference in serious maternal morbidity or death (RR 0.20, 95% CI 0.01 to 4.12; 4 studies; 1481 women) or five-minute Apgar score < 7 (RR 0.74, 95% CI 0.49 to 1.14; 4271 women; 14 studies) because the quality of the evidence was found to be very low and low, respectively.Balloon versus low-dose vaginal misoprostol: it is uncertain whether there is a difference in vaginal deliveries not achieved within 24 hours between induction of labour with a balloon catheter and vaginal misoprostol (RR 1.09, 95% CI 0.85 to 1.39; 340 women; 2 studies; low-quality evidence). A balloon catheter probably reduces the risk of uterine hyperstimulation with FHR changes (RR 0.39, 95% CI 0.18 to 0.85; 1322 women; 8 studies; moderate-quality evidence) but may increase the risk of a caesarean section (average RR 1.28, 95% CI 1.02 to 1.60; 1756 women; 12 studies; I² = 45%; low-quality evidence). It is uncertain whether there is a difference in serious neonatal morbidity or perinatal death (RR 0.58, 95% CI 0.12 to 2.66; 381 women; 3 studies), serious maternal morbidity or death (no events; 4 studies, 464 women), both very low-quality evidence, and five-minute Apgar score < 7 (RR 1.00, 95% CI 0.50 to 1.97; 941 women; 7 studies) and NICU admissions (RR 1.00, 95% CI 0.61 to 1.63; 1302 women; 9 studies) both low-quality evidence.Balloon versus low-dose oral misoprostol: a balloon catheter probably increases the risk of a vaginal delivery not achieved within 24 hours (RR 1.28, 95% CI 1.13 to 1.46; 782 women, 2 studies, and probably slightly increases the risk of a caesarean section (RR 1.17, 95% CI 1.04 to 1.32; 3178 women; 7 studies; both moderate-quality evidence) when compared to oral misoprostol. It is uncertain whether there is a difference in uterine hyperstimulation with FHR changes (RR 0.81, 95% CI 0.48 to 1.38; 2033 women; 2 studies), serious neonatal morbidity or perinatal death (RR 1.11, 95% CI 0.60 to 2.06; 2627 women; 3 studies), both low-quality evidence, serious maternal morbidity or death (RR 0.50, 95% CI 0.05 to 5.52; 2627 women; 3 studies), very low-quality evidence, five-minute Apgar scores < 7 (RR 0.71, 95% CI 0.38 to 1.32; 2693 women; 4 studies) and NICU admissions (RR 0.82, 95% CI 0.58 to 1.17; 2873 women; 5 studies) both low-quality evidence. AUTHORS' CONCLUSIONS: Low- to moderate-quality evidence shows mechanical induction with a balloon is probably as effective as induction of labour with vaginal PGE2. However, a balloon seems to have a more favourable safety profile. More research on this comparison does not seem warranted.Moderate-quality evidence shows a balloon catheter may be slightly less effective as oral misoprostol, but it remains unclear if there is a difference in safety outcomes for the neonate. When compared to low-dose vaginal misoprostol, low-quality evidence shows a balloon may be less effective, but probably has a better safety profile.Future research could be focused more on safety aspects for the neonate and maternal satisfaction

Does the New FIGO 2018 Staging System Allow Better Prognostic Differentiation in Early Stage Cervical Cancer?: A Dutch Nationwide Cohort Study

The FIGO 2018 staging system was introduced to allow better prognostic differentiation in cervical cancer, causing considerable stage migration and affecting treatment options. We evaluated the accuracy of the FIGO 2018 staging in predicting recurrence free (RFS) and overall survival (OS) compared to FIGO 2009 staging in clinically early stage cervical cancer. We conducted a nationwide retrospective cohort study, including 2264 patients with preoperative FIGO (2009) IA1, IA2 and IB1 cervical cancer between 2007-2017. Kaplan-Meier analyses were used to assess survival outcomes. Logistic regression was used to assess risk factors for lymph node metastasis and parametrial invasion. Stage migration occurred in 48% (22% down-staged, 26% up-staged). Survival data of patients down-staged from IB to IA1/2 disease were comparable with FIGO 2009 IA1/2 and better than patients remaining stage IB1. LVSI, invasion depth and parametrial invasion were risk factors for lymph node metastases. LVSI, grade and age were associated with parametrial invasion. In conclusion, the FIGO 2018 staging system accurately reflects prognosis in early stage cervical cancer and is therefore more suitable than the FIGO 2009 staging. However subdivision in IA1 or IA2 based on presence or absence of LVSI instead of depth of invasion would have improved accuracy. For patients down-staged to IA1/2, less radical surgery seems appropriate, although LVSI and histology should be considered when determining the treatment plan