The Efficacy and Safety of Dinoprostone Vaginal Insert for Labor Induction Following Optimization of Standard Operating Procedure: A Retrospective Study in China

Background:The study aimed to assess the efficacy and safety of dinoprostone vaginal insert in labor induction following optimization of standard operating procedure(SOP)and to discover independent predictors of vaginal delivery.Methods:This study comprised 551 pregnant women who required cervical ripening with dinoprostone before induction of labor.Using univariate and multivariate analyses,independent predictors of vaginal delivery were identified.Results:443 of the 551 women(80.4%)gave birth vaginally.Vaginal delivery was predicted by maternal age(24-30 vs.<24,P<0.001;30-35 vs.<24,P=0.03),gestational age(P=0.005),birth weight(P<0.001),parity(P=0.001),pre-pregnancy BMI(P<0.001),premature rupture of membranes(P=0.001),meconium-stained amniotic fluid(P<0.001),fundal height(P<0.001)and the Bishop score(P<0.001).None of the women exhibited severe postpartum hemorrhage.Conclusions:The maternal age,gestational age,birth weight,parity,body mass index,premature membrane rupture,amniotic fluid contamination,fundal height,and the Bishop score were independent predictors of vaginal delivery.These may guide the clinical use of dinoprostone for induction of labor.

Low-Dose Misoprostol versus Vaginal-Insert Dinoprostone for At-Term Labor Induction: A Prospective Cohort Study

Introduction: Given the pharmacological change taking place in Spanish delivery rooms, we designed this study to compare the effectiveness and safety of misoprostol (25 mcg/4h) to 10 mg dinoprostone in its slow-releasing vaginalinsert form to induce at-term labor. Methods: In a prospective cohort study (2013-2015), 401 at-term pregnant women referred for induction (Bishop score ≤ 6), who gave birth at the Rey Juan Carlos Hospital in Móstoles (Madrid, Spain), of whom 241 participants were induced with misoprostol and 160 with dinoprostone. Patients were recruited by non-probabilistic sampling of consecutive cases as the inductions in the Obstetrics Block during the study period were indicated. Results: The cesarean section rate was 14% for the misoprostol group and 19% for the dinoprostone group [RR = 1.38 (95%CI: 0.89 - 2.13), p = 0.145]. No differences were found in the vaginal birth rate in <24 h from starting induction [44% vs. 53%, RR = 1.08 (0.90 - 1.29), p = 0.401], nor in the vaginal birth rate in <12 h, requiring oxytocin or meconium fluid, or for maternal-neonatal complications deriving from the method employed. The percentage of cesarean sections due to failed induction was lower in the misoprostol group (15% vs. 39%, p = 0.028). The time between induction and giving birth was shorter for the dinoprostone group (20 h vs. 23.4 h, p = 0.018). Conclusion: Inducing delivery by low-dose misoprostol offers similar effectiveness and safety to induction by dinoprostone in its slow-releasing vaginal-insert form. However, our sample is limited, and few studies are available on the subject. Further analyses to draw solid conclusions are required.

A Comparative Study on the Effects of Vaginal Misoprostol and Vaginal Misoprostol Plus Estradiol on Labor Induction

Background:Cervical ripening is an important factor in predicting successful labor induction.In an unfavorable cervix,ripening should be done before induction.In this study,the effect of misoprostol and that of misoprostol plus estradiol on cervical ripening were compared.Methods:This randomized,double-blinded study included a total of 190 pregnant women who were identified for pregnancy termination due to maternal or fetal cause at 37 weeks with Bishop score of less than 4.The patients were assessed between April 2015 to April 2016 in two university hospitals at northeast Iran(Omol-Banin Hospital and Emam Reza Hospital,Mashhad).The patients who met the inclusion criteria were randomly assigned to two groups:the intervention group(Group A),who received 25 micrograms of vaginal misoprostol plus 50 micrograms of estradiol,and the control group(Group B),who received 25 micrograms of vaginal misoprostol only.Misoprostol was administered at 4-hour intervals until cervical ripening(Bishop score≥8)or upon initiation of active phase in both the groups.The maximum dosage of misoprostol was three doses,whereas estradiol was administered only once.Results:In this study,the main causes of pregnancy termination were ROM and post-term.There was no significant statistical difference in the Bishop score between the two groups(P=0.13).In addition,no significant difference was observed in the duration of time for cervical ripening(Bishop≥8)between the two groups(P=0.7).The duration between drug administration to the initiation of active phase and also from active phase to delivery showed no significant differences between the two groups(P=0.49 and 0.24,respectively).There was also no significant difference in the delivery route(operative vaginal delivery or Cesarean section)(P=0.2 and P=0.91,respectively).Conclusion:From this study,the use of misoprostol plus estradiol did not improve cervical ripening or decrease the induction time.Further studies are recommended to investigate complementary results.

Effectiveness of Dinoprostone and Cook's Balloon for Labor Induction in Primipara Women at Term

Labor induction is commonly used for achieving successful vaginal delivery.This study aimed to compare the effectiveness of dinoprostone and Cook's balloon as labor-inducing agents in primipara women at term.A retrospective cohort study among primipara women was conducted in Hubei Maternity and Child Health Hospital.Basic clinical characteristics were collected.The main outcomes were vaginal delivery rate,cesarean section rate and forceps delivery rate.Obstetric and perinatal outcomes were also compared.Univariate and multivariate analyses were further performed to evaluate the predictors for vaginal delivery within 24 h.A total of 845 eligible primipara women undergoing labor induction were recruited.Of them,141 women were induced with dinoprostone(dinoprostone group,DG),and 704 with Cook's balloon(Cook's balloon group,CG).Groups were homogeneous except more women with premature rupture of membranes in DG,with gestational hypertension in CG(P<0.05).The vaginal delivery rate within 12 h was 1.98%and 16.52%in CG and DG respectively(P=0.0001).Besides,the vaginal delivery rate within 24 h was 37.62%and 52.26%in CG and DG respectively(P=0.0079).DG showed the lower rate of oxytocin augmentation,artificial rupture of membrane and postpartum hemorrhage and the shorter interval from insertion to active labor than CG(P<0.05).Multivariate regression analysis revealed that abortion history,oxytocin augmentation,artificial rupture of membrane,and obstric analgesia were independent predictors for vaginal delivery within 24 h.In conclusion,dinoprostone was more effective than Cook's balloon to induce labor and achieve vaginal birth in the sample of primipara women at term.

Is Induction of Labor with Early Rupture of Membranes Associated with an Increased Rate of Clinical Chorioamnionitis?

Objective: The objective of this study was to determine if early rupture of membranes (ROM) in women undergoing induction of labor (IOL) at term is associated with an increased rate of clinical chorioamnionitis. Study Design: A retrospective cohort study was performed on women undergoing IOL. Early ROM was defined as ROM at a modified Bishop score less than 5, cervical dilation less than 4 cm, or cervical effacement less than 80%. The rate of clinical chorioamnionitis was compared between women with early and late ROM. Results: The rate of clinical chorioamnionitis was 8.6% (24/279). ROM at an effacement of less than 80% was associated with a rate of clinical chorioamnionitis of 15.4% (12/78) compared to 6.0% (12/201) at an effacement of equal to or greater than 80%, p = 0.017. The rate of cesarean delivery was higher for patients with early ROM by any definition: 32% compared to 17.5% by modified Bishop score (p = 0.031), 32.4% versus 18.2% by cervical dilation (p = 0.049), and 33.3% versus 14.9% by cervical effacement (p = 0.001). Conclusions: In patients undergoing IOL, early ROM may be associated with an increased rate of clinical chorioamnionitis when performed at a cervical effacement of less than 80% and an increased rate of cesarean delivery.

Cervical Ripening for Induction of Labor: A Randomized Comparison between Vaginal Misoprostol versus Foley’s Catheter Placement in a Nigeria Tertiary Hospital

Background: Cervical ripening is prerequisite of successful induction of labor. Vaginal misoprostol and Foley’s catheter placement have been widely used for this purpose but the data are not always sufficient. We attempted to determine which (misoprostol versus Foley’s catheter) is more effective/safer in Nigerian setting. Methods: A randomized controlled trial was performed at Federal Teaching Hospital Abakaliki, Nigeria, involving 135 term pregnant women requiring cervical ripening and labor induction. Participants were randomly allocated to misoprostol versus catheter group. The following were recorded/measured/analyzed: Bishop’s score, age, parity, body mass index, gestational age, labor duration, indication, oxytocin use, mode of delivery, and Apgar score. Chi square test and t test were used where appropriate. Results: At 24 hours, all of misoprostol group were either in labor, had ripe cervix, or had delivered, whereas 35.4% of catheter group had still unripe cervix (x2 = 29.856, P = 0.0001). Misoprostol group was less likely to require oxytocin infusion (x2 = 52.600, P = 0.0001) and less likely to require cesarean delivery (cesarean: misoprostol versus catheter: 11% versus 34% (x2 = 9.800, P = 0.001)). Total medical cost for misoprostol was less than that of catheter (x2 = 14.703, P = 0.0001). Conclusion: 50 μg vaginal misoprostol, compared with catheter placement, was more effective, cheaper, and safe as a procedure of cervical ripening before induction of labor.

Comparison of the effectiveness and pregnancy outcomes of labor induction with dinoprostone or single-balloon catheter in term nulliparous women with borderline oligohydramnios

Backgrounds:At present,there is no consensus on the induction methods in term pregnancy with borderline oligohydramnios.This study aimed to compare the effectiveness and pregnancy outcomes of labor induction with dinoprostone or single-balloon catheter(SBC)in term nulliparous women with borderline oligohydramnios.Methods:We conducted a retrospective cohort study from January 2016 to November 2018.During the study period,a total of 244 cases were enrolled.Of these,103 cases were selected for induction using dinoprostone and 141 cases were selected for induction with SBC.The pregnancy outcomes between the two groups were compared.Primary outcomes were successful vaginal delivery rates.Secondary outcomes were maternal and neonatal adverse events.Multivariate logistic regression was used to assess the risk factors for vaginal delivery failure in the two groups.Results:The successful vaginal delivery rates were similar between the dinoprostone group and the SBC group(64.1%[66/103]vs.59.6%,[84/141]P=0.475),even after adjustment for potential confounding factors(adjusted odds ratio[aOR]:1.07,95%confidence interval[CI]:0.57-2.00,P=0.835).The incidence of intra-amniotic infection was lower in the dinoprostone group than in the SBC group(1.9%[2/103]vs.7.8%[11/141],P<0.001),but the presence of non-reassuring fetal heart rate was higher in the dinoprostone group than in the SBC group(12.6%[13/103]vs.0.7%,[1/141]P<0.001).Multivariate logistic regression showed that nuchal cord was a risk factor for vaginal delivery failure after induction with dinoprostone(aOR:6.71,95%CI:1.96-22.95).There were three factors related to vaginal delivery failure after induction with SBC,namely gestational age(aOR:1.51,95%CI:1.07-2.14),body mass index(BMI)>30 kg/m^(2)(aOR:2.98,95%CI:1.10-8.02),and fetal weight>3500 g(aOR:2.49,95%CI:1.12-5.50).Conclusions:Term nulliparous women with borderline oligohydramnios have similar successful vaginal delivery rates after induction with dinoprostone or SBC,with their advantages and disadvantages.In women with nuchal cord,the risk of vaginal delivery failure is increased if dinoprostone is used in the induction of labor.BMI>30 kg/m^(2),large gestational age,and estimated fetal weight>3500 g are risk factors for vaginal delivery failure after induction with SBC.

Transvaginal Sonographic Assessment of the Cervix for Prediction of Successful Induction of Labor in Nulliparous Women

Background: Induction of labor is commonly performed in obstetric practice. Many methods have been suggested as good predictors of the outcome of labor induction, yet none of them is satisfactory enough. Our study aims to assess cervical length and uterocervical angle measured by transvaginal ultrasound as predictors of successful induction of labor. Methods: Prospective cohort study conducted in Ain Shams University Maternity hospital over 150 nulliparous women undergoing induction of labor, in the period between May 2018 and August 2019. Transvaginal sonographic measurement of cervical length and uterocervical angle was done before induction of labor by prostaglandins. The patients were followed up till delivery and the outcome was recorded. Results: The best cut-off value of cervical length for prediction of success of labor induction was 32.3 mm with 60% sensitivity and 56% specificity and the best cut-off value of uterocervical angle was 110.2 degrees with 87% sensitivity and 93% specificity. The cervical length showed a significant negative correlation while the uterocervical angle showed a significant positive correlation with the success of labor induction. Conclusion: Cervical length and uterocervical angle are good predictors of successful labor induction.

Birthing ball on promoting cervical ripening and its influence on the labor process and the neonatal blood gas index

BACKGROUND Term pregnancy-induced labor refers to the use of artificial methods to induce uterine contractions and terminate pregnancy after 37 wk.It is a common method to prevent overdue pregnancy and to deal with high-risk pregnancies.In addition,it can alleviate maternal complications and cause the fetus to leave the adverse intrauterine environment early,which is beneficial to the outcome of pregnancy.AIM To explore the effect of a birthing ball on labor by inducing cervical ripening and its influence on labor and the neonatal blood gas index.METHODS Twenty-two women who were scheduled to undergo labor induction and delivery in the obstetrics department of our hospital were randomly divided into two groups:the delivery ball group(childbirth ball combined with COOK balloon induction)and the conventional group(COOK balloon induction alone).The cervical Bishop score before and after intervention,duration of labor at each stage,mode of delivery,neonatal umbilical venous blood pH,oxygen partial pressure(PO_(2)),carbon dioxide partial pressure(PCO_(2)),and the 1-min Apgar score were recorded.RESULTS After the intervention,the cervical Bishop score of the delivery ball group(7.84±1.52)was significantly higher than that of the conventional group(7.32±1.29)(P<0.05),and the cervical Bishop scores of the two groups after intervention were significantly higher than those before intervention(P<0.05).After the intervention,the first stage of labor(510.9±98.7 min),the second stage of labor(43.0±8.5 min),and the total duration of labor(560.0±120.9 min)in the delivery ball group were lower than those in the routine group,with a first stage of labor of 602.1±133.2 min,a second stage of labor of 48.4±9.1 min,and a total duration of labor of 656.8±148.5 min(P<0.05).There was no significant difference in the time of the third stage of labor between the two groups(P>0.05).There was no significant difference in the pH,PO_(2),and PCO_(2) values of newborns between the delivery ball group and the conventional group(P>0.05).The 1-min Apgar score of the delivery ball group was higher than that of the conventional group(9.10±0.38 points vs 8.94±0.31 points,P<0.05).The natural delivery rate of the delivery ball group was higher than that of the conventional group(91.00%vs 78.00%,P<0.05).CONCLUSION The use of a birthing ball combined with a COOK balloon for inducing labor has a better effect on promoting cervical ripening,shortening the time of labor,and improving the Apgar score of newborns.

Efficacy and Safety of Misoprostol Vaginal Insert to Induce Labor beyond 40 + 0 Weeks of Gestation

Objective: Misoprostol vaginal insert (MVI) is proven to induce labor by a continuously release of PGE1. Previous reports showed that MVI reduced induction to delivery time as well as active labor time but it also increased uterine tachysystole. Here we attempted to clarify whether MVI is safe and efficient for women with pregnancies >40 weeks in a single institute. Methods: This study was performed in Lutheran Hospital Bergisch Gladbach, Germany 2014-2019. A total of 304 women between 40 + 0 to 42 + 0 weeks underwent labor induction with MVI. Outcomes were: 1) maternal: time from insertion to delivery, interventions, mode of delivery, and uterine tachysystole, 2) neo-natal: cord blood pH, APGAR scores, and admission to a neonatal clinic. This study ended unexpectedly due to the withdrawal of MVI (MisodelTM) in September 2019. Results: 75.7% (n = 230) of women gave birth within 24 hours after MVI placement. 72.2% (n = 140) nulliparous women and 81.8% (n = 90) parous women delivered within 24 hours. In two cases emergency CS was required. 67.8% (n = 206) of women delivered vaginal. 2.3% (n = 7) of cord pH levels were below 7.10. 3.3% (n = 10) of newborns were transmitted to a neonatal clinic. Conclusion: MVI is an efficient method to induce labor for pregnant women beyond 40 + 0 weeks. However, considering various complications observed (uterine tachysystole and fetal distress leading to a high number of CS), we cannot universally advocate the use of MVI.

A Qualitative Study on the Psychological Experience of Pregnant Women with Abnormal Induced Abortion of Fetuses under 20 Weeks of Pregnancy

Objective: This paper aims to understand the psychological experience and needs of pregnant women who need induction of labor due to fetal abnormalities at less than 20 weeks of gestation through in-depth interviews. Methods: Using the phenomenological research method in qualitative research, 12 pregnant women with fetal abnormalities less than 20 weeks of gestation in the obstetrics department of a hospital from January to April 2023 were selected as the research objects for semi-structured in-depth interviews. After information was collected to saturation, Colaizzi content analysis method was used to sort out, analyze and refine the data. Results: Through the interview results, three themes were refined from the transcript. Those are: 1) the support and assistance needed during the induction of labor;2) inner feelings after labor induction;3) The vision of future life. Conclusion: Abnormal fetal development at <20 weeks of gestation can cause anxiety, depression, guilt, loneliness and other negative emotions for pregnant women, and they need to get corresponding psychological support, especially during the period from fetal abnormality to induction of labor, pregnant women have to experience many physical and mental suffering, and need to get the care of family, relatives, friends, medical staff and society. Medical staff can help them seek multi-directional support, provide professional knowledge, and help them with self-management.

Effectiveness and Safety of Double-balloon Catheter versus Intra-amniotic Injection of Ethacridine Lactate for Termination of Second Trimester Pregnancy in Patients with Liver Dysfunction

Severe liver dysfunction in pregnancy（SLDP） is rare but serious complications with high mortality rate. This study compared the effectiveness and safety of double-balloon catheter versus intra-amniotic injection of ethacridine lactate for the termination of second trimester pregnancy in patients with SLD. A total of 55 patients with indications of labor induction were enrolled and analyzed by retrospective control analysis method. Twenty-three cases adopted Cook double balloon dilation as Cook group, and 32 cases received intra-amniotic injection of ethacridine lactate as EL group. The primary outcome was evaluated by successful abortion rate and the difference in the induction-to-abortion interval. Secondary outcomes included liver function recovery and the frequency of adverse events. Both Cook and EL regimens were effective, with successful abortion rate of 87.0% and 93.8%, respectively（P=0.639）. The induction-to-delivery interval was similar between Cook group and EL group（38.1±21.5 vs. 41.3±17.4, P=0.543）. The liver disease status was more severe in Cook group than in EL group, but it did not show any significant difference after pregnancy termination between the two groups and the improvement rate also did not show any significant difference. Both treatments were safe and there was no significant difference in bleeding and cervical laceration adverse events between the two groups. Our study firstly compared double-balloon catheter and ethacridine lactate for the induction of labor in women with SLD during second trimester pregnancy.

Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women： A Double-blinded, Prospective Randomized Controlled Study

Background： In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety ofintravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. Methods： This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7：2. lntravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h （repeated tip to 3 times） for labor induction. Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 1211 or vaginal delivery within 24 h. Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes. Results： A total of 173 women for misoprostol group and 49 women for placebo were analyzed. The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo （64.2% vs. 22.5%, relative risk [RR]： 2.9, 95% confidence interval [C/]： 1.4-6.0）. The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group （48.0% vs. 18.4%, RR： 2.6, 95% CI： 1.2-5.7）; and the induction-onset of labor interval was significantly shorter in the misoprostol group （P = 0.0003）. However, there were no significant differences in the median process time of vaginal labor （6.4 vs. 6.8 h; P = 0.695）, incidence （39.3% vs. 49.0%, RR： 0.8, 95% CI： 0.4-1.5） and indications （P = 0.683） of cesarean section deliveries, and frequencies of maternal, fetal/neonatal adverse events between the groups. Conclusion： Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening.

Impact of Early versus Late Amniotomy on Induction of Labor in Nulliparous Women after Vaginally Administered Misoprostol: A Randomized Clinical Trial

Objective::To investigate the effect of early versus late amniotomy after induction of labor(IOL)with vaginally administered misoprostol.Methods::This randomized clinical trial was conducted at the Department of Obstetrics and Gynecology,Menoufia University,from May 2019 to March 2020,and included 120 nulliparous women at term(≥37 weeks’gestation)undergoing IOL.Computer-generated randomization was used to randomize the participants into either the early amniotomy group(3 cm cervical dilatation;n=60)or the late amniotomy group(7 cm cervical dilatation;n=60).All participants received misoprostol(25μg)vaginally to induce labor.The primary outcome was the induction-to-delivery interval,defined as the time from the initiation of IOL to the time of delivery.Results::Women in the early amniotomy group had a shorter duration of labor(12.60±5.36 h)than those in the late amniotomy group(16.67±7.26 h).The mean time from rupture of the fetal membrane to delivery was significantly shorter in the late(2.51±0.36 h)than in the early amniotomy group(3.1±0.89 h).There was no statistically significant difference between the groups in terms of maternal complications(fever,nausea,vomiting,and uterine hyperstimulation)or neonatal complications(meconium-stained liquor,APGAR score<7 at 1 and 5 min,and neonatal intensive care unit admission).Conclusions::IOL using vaginally administered misoprostol followed by early amniotomy was accompanied by a shorter duration of labor and decreased use of oxytocin.There was no significant difference between the early and late amniotomy groups in terms of the rate of cesarean section or maternal and neonatal complications.