scholarly journals MEchanical DIlatation of the Cervix­­ in a Scarred uterus (MEDICS): the study protocol of a randomised controlled trial comparing a single cervical catheter balloon and prostaglandin PGE2 for cervical ripening and labour induction following caesarean delivery

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e028896
Author(s):  
Soe-Na Choo ◽  
Abhiram Kanneganti ◽  
Muhammad Nur Dinie Bin Abdul Aziz ◽  
Leta Loh ◽  
Carol Hargreaves ◽  
...  
Keyword(s):  
Vaginal Delivery ◽  
Caesarean Delivery ◽  
Controlled Trial ◽  
Foley Catheter ◽  
Rate Of Change ◽  
Cervical Ripening ◽  
Labour Induction ◽  
High Risk Population ◽  
Active Labour ◽  
Uterine Hyperstimulation

IntroductionLabour induction in women with a previous caesarean delivery currently uses vaginal prostaglandin E2 (PGE2), which carries the risks of uterine hyperstimulation and scar rupture. We aim to compare the efficacy of mechanical labour induction using a transcervically applied Foley catheter balloon (FCB) with PGE2 in affected women attempting trial of labour after caesarean (TOLAC).Methods and analysisThis single-centre non-inferiority prospective, randomised, open, blinded-endpoint study conducted at an academic maternity unit in Singapore will recruit a total of 100 women with one previous uncomplicated caesarean section and no contraindications to vaginal delivery. Eligible consented participants with term singleton pregnancies and unfavourable cervical scores (≤5) requiring labour induction undergo stratified randomisation based on parity and are assigned either FCB (n=50) or PGE2 (n=50). Treatments are applied for up to 12 hours with serial monitoring of the mother and the fetus and serial assessment for improved cervical scores. If the cervix is still unfavourable, participants are allowed a further 12 hours’ observation for cervical ripening. Active labour is initiated by amniotomy at cervical scores of ≥6. The primary outcome is the rate of change in the cervical score, and secondary outcomes include active labour within 24 hours of induction, vaginal delivery, time-to-delivery interval and uterine hyperstimulation. All analyses will be intention-to-treat. The data generated in this trial may guide a change in practice towards mechanical labour induction if this proves efficient and safer for women attempting TOLAC compared with PGE2, to improve labour management in this high-risk population.Ethics and disseminationEthical approval is granted by the Domain Specific Review Board (Domain D) of the National Healthcare Group, Singapore. All adverse events will be reported within 24 hours of notification for assessment of causality. Data will be published and will be available for future meta-analyses.Trial registration numberNCT03471858; Pre-results.

scholarly journals Foley Catheter versus Vaginal Misoprostol for Labour Induction

2015 ◽  
Vol 2015 ◽  
pp. 1-4 ◽  
Author(s):  
Nasreen Noor ◽  
Mehkat Ansari ◽  
S. Manazir Ali ◽  
Shazia Parveen
Keyword(s):  
Vaginal Delivery ◽  
Foley Catheter ◽  
Labour Induction ◽  
Sterile Saline ◽  
Group I ◽  
Catheter Group ◽  
Uterine Hyperstimulation ◽  
Spss Software ◽  
Vaginal Misoprostol ◽  
Foley’S Catheter

Objectives. To compare the efficacy and safety of intravaginal misoprostol with transcervical Foley catheter for labour induction.Material and Methods. One hundred and four women with term gestation, with Bishop score < 4, and with various indications for labour induction were randomly divided into two groups. In Group I, 25 μg of misoprostol tablet was placed intravaginally, 4 hourly up to maximum 6 doses. In Group II, Foley catheter 16F was placed through the internal os of the cervix under aseptic condition and then inflated with 50 cc of sterile saline. Statistical analysis was done using SPSS software.Results. The induction to delivery interval was 14.03 ± 7.61 hours versus 18.40 ± 8.02 hours (p<0.01). The rate of vaginal delivery was 76.7% versus 56.8% in misoprostol and transcervical Foley catheter group, respectively. Uterine hyperstimulation was more common with misoprostol. Neonatal outcome was similar in both the groups.Conclusion. Intravaginal misoprostol is associated with a shorter induction to delivery interval as compared to Foley’s catheter and it increases the rate of vaginal delivery in cases of unripe cervix at term. Transcervical Foley catheter is associated with a lower incidence of uterine hyperstimulation during labour.

Controlled Release Dinoprostone Insert and Foley Compared to Foley Alone: A Randomized Pilot Trial

2020 ◽  
Author(s):  
Rodney K. Edwards ◽  
Michelle L. Norris ◽  
Mitchell D. West ◽  
Christina Zornes ◽  
Katherine A. Loeffler ◽  
...  
Keyword(s):  
Vaginal Delivery ◽  
Controlled Trial ◽  
Foley Catheter ◽  
Pilot Trial ◽  
Cervical Ripening ◽  
Open Label ◽  
Cumulative Incidence Functions ◽  
Uterine Incision ◽  
Nulliparous Women ◽  
Incidence Functions

Abstract Objective The aim of study is to compare, in a pilot study, combined dinoprostone vaginal insert and Foley catheter (DVI + Foley) with Foley alone (Foley) for cervical ripening and labor induction at term. Study Design In this open-label pilot randomized controlled trial, women not in labor, with intact membranes, no prior uterine incision, an unfavorable cervix, gestational age ≥37 weeks, and a live, nonanomalous singleton fetus in cephalic presentation were randomly assigned, stratified by parity, to DVI + Foley or Foley. Oxytocin was used in both groups after cervical ripening. Primary outcome was time to vaginal delivery. Results From April 2017 to January 2018, 100 women were randomized. Median (25–75th percentile) time to vaginal delivery for nulliparous women was 21.2 (16.6–38.0) hours with DVI + Foley (n = 26) compared with 31.3 (23.3–46.9) hours with Foley (n = 24) (Wilcoxon p = 0.05). Median time to vaginal delivery for parous women was 17.1 (13.6–21.9) hours with DVI + Foley (n = 25) compared with 14.8 (12.7–19.5) hours with Foley (n = 25) (Wilcoxon p = 0.21). Results were also analyzed to consider the competing risk of cesarean using cumulative incidence functions. Conclusion Compared with Foley alone, combined use of the dinoprostone vaginal insert and Foley for cervical ripening may shorten time to vaginal delivery for nulliparous but not parous women.

scholarly journals Profiling cervical ripening for induction of labour with Foley’s balloon catheter in Ebonyi state, Nigeria: a randomized controlled trial

2021 ◽  
Vol 10 (1) ◽  
pp. 22
Author(s):  
Nnabugwu Alfred Adiele ◽  
Christian C. Mgbafulu ◽  
Arinze Chidiebere Ikeotuonye ◽  
Christian Chidebe Anikwe ◽  
Joshua Adeniyi Adebayo ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Foley Catheter ◽  
Balloon Catheter ◽  
Active Phase ◽  
Induction Of Labour ◽  
Cervical Ripening ◽  
Labour Induction ◽  
Controlled Study ◽  
Bishop Score ◽  
Randomized Controlled

Background: The ripeness of the cervix is an important prerequisite to a successful labour induction. Use of extra-amniotic Foley catheter is a mechanical method of cervical ripening with proven efficacy. This study compared the difference in efficacy between 30 ml and 60 ml of water for inflation of Foley catheter balloon when used for cervical ripening during induction of labour.Methods: A single-blind randomized controlled study where 260 term pregnant women with intact membranes and unfavourable cervix were selected for induction of labour and randomized into two equal groups (30 ml- and 60 ml- groups) from October, 2019 to July 2020. Each participant had cervical ripening with the catheter bulb inflated with either 30 ml or 60 ml of sterile water (as assigned to the individual). After achieving favourable cervix (BS ≥6), oxytocin titration was commenced and the labour monitored with the outcomes well documented and statistically analysed.Results: Mean duration to favourable Bishop Score significantly reduced in the 60 ml group (10.8 hours±2.99) as against 12.7 hours±10.0 in 30ml group (p=0.038). Mean duration of active phase of labour was significantly reduced in 60 ml group (5.6 hours±2.4) as against 8.4 hours±3.2 in 30 ml group (p=0.010). Caesarean delivery rate was significantly reduced in the 60 ml groups (p=0.027).Conclusions: The use of 60 ml inflated Foley’s balloon catheter when compared with 30mls to ripen the cervix effectively reduced the duration to favourable Bishop Score, duration of the active phase of labour and the rate of Caesarean sections.  

scholarly journals Induction of labour after 37 weeks of pregnancy using foley’s catheter: traction versus non-traction method

2020 ◽  
Vol 10 (1) ◽  
pp. 275
Author(s):  
Jaydeep J. Bhatu ◽  
Disha Patel
Keyword(s):  
Pregnant Women ◽  
Vaginal Delivery ◽  
Controlled Trial ◽  
Foley Catheter ◽  
Mode Of Delivery ◽  
Induction Of Labour ◽  
Labour Induction ◽  
Unfavourable Cervix ◽  
Foley’S Catheter ◽  
Traction Group

Background: Cervical Foley’s catheter used now a days for induction of labour alone as well as a combined with cerviprim gel. The objective of the study was to assess the effectiveness of 750 cc traction on Foley catheter with no traction for labour induction in >37 weeks pregnancy.Methods: A randomized controlled trial performed on pregnant women at >37 weeks who were admitted for induction of labour with unfavourable cervix. They were randomly assigned into two groups, Foley’s with 750 cc traction and without traction. The primary outcomes were improvement in Bishop Score, number of favourable cervix following induction and the mode of delivery. The secondary outcomes were neonatal outcome, and maternal infection.Results: A total of 80 pregnant women were randomized into traction group (n=46) and non-traction group (n=34). Traction group had significantly (p=0.0462) higher number of vaginal delivery compared to non-traction group. Participants were comfortable using both methods. There was no difference in neonatal outcomes and risk of maternal infections in both groups.Conclusions: Application of traction did result in more vaginal delivery.

scholarly journals Comparison of titrated oral misoprostol solution versus vaginal misoprostol for induction of labour in term obstetric patients for obstetric and neonatal outcomes: a randomized controlled trial

2018 ◽  
Vol 7 (6) ◽  
pp. 2339
Author(s):  
Puneeta Mahajan ◽  
Rajendra Popatrao Shitole
Keyword(s):  
Vaginal Delivery ◽  
Controlled Trial ◽  
Oral Solution ◽  
Cervical Ripening ◽  
Labour Induction ◽  
P Value ◽  
Oral Misoprostol ◽  
Unfavourable Cervix ◽  
Oral Group ◽  
Vaginal Misoprostol

Background: With more than 15% of all gravid women requiring prostaglandins in cervical ripening and labour induction. However, evidence is not clear about the preferred route or dose of the drug. So this study was designed with objectives to compare the induction delivery interval and safety of titrated oral misoprostol solution with vaginal misoprostol for labour induction in term primigravida women.Methods: In this randomised controlled trial out of 576 eligible women, 220 women as per inclusion criteria between 37 and 42 weeks of gestation with an unfavourable cervix (Bishop score <6) with indication for labour induction were randomly assigned (110each) to receive titrated oral solution of 20 mL misoprostol solution (1 mcg/mL) every 1 hour for four doses and then were titrated against individual uterine response or vaginal misoprostol 25 mcg every 4 hours. Vaginal delivery within 12 hours was the primary outcome. The data were analyzed by intention-to-treat.Results: Vaginal delivery occurred within 12 hours in 56 (50.9%) women in the titrated oral group and 24 (21.8%) women in the vaginal group with significant p-value (<0.001). The incidence of caesarean, hyper stimulation, low apgar score was less in the titrated oral group. More women experienced nausea in the titrated oral group.Conclusions:Titrated oral misoprostol is safe and effective for labour induction in primigravida patients with unfavourable cervix. 

scholarly journals The Successful Use of Nitroglycerin for Uterine Hyperstimulation with Fetal Heart Rate Abnormality Caused by a Controlled-Release Dinoprostone Vaginal Delivery System (PROPESS): A Case Report

Medicina ◽  
2021 ◽  
Vol 57 (5) ◽  
pp. 478
Author(s):  
Sho Takakura ◽  
Hiroaki Tanaka ◽  
Naosuke Enomoto ◽  
Shintaro Maki ◽  
Tomoaki Ikeda
Keyword(s):  
Heart Rate ◽  
Controlled Release ◽  
Vaginal Delivery ◽  
Delivery System ◽  
Fetal Heart Rate ◽  
Fetal Heart ◽  
Cervical Ripening ◽  
Emergency Cesarean ◽  
Uterine Hyperstimulation ◽  
Uterine Relaxation

The PROPESS, a controlled-release dinoprostone vaginal delivery system, is a pharmacological cervical ripening intervention and promotes cervical change causing uterine contraction. During insertion of the PROPESS, uterine hyperstimulation could occur and result in fetal heart rate (FHR) abnormality. We report a case of uterine hyperstimulation accompanied with FHR abnormality caused by the PROPESS in a pregnant woman. Postural change, oxygenation, fluid infusion, and the immediate PROPESS removal were ineffective to address the adverse event, so we administered nitroglycerin for acute uterine relaxation. The nitroglycerin resulted in uterine relaxation, and the FHR abnormality was resolved immediately, thereby preventing an emergency cesarean section. Therefore, nitroglycerin could be considered an effective option for uterine hyperstimulation accompanied with FHR abnormality caused by the PROPESS.

scholarly journals A comparative study of intra-cervical foley’s catheter and PGE2 gel for induction of labour at term

2019 ◽  
Vol 8 (9) ◽  
pp. 3689
Author(s):  
Anjali R. Kanada ◽  
Mahima Jain
Keyword(s):  
Side Effects ◽  
Caesarean Section ◽  
Comparative Study ◽  
Foley Catheter ◽  
Induction Of Labour ◽  
Cervical Ripening ◽  
Labour Induction ◽  
Mechanical Methods ◽  
Significant Difference ◽  
Foley’S Catheter

Background: In cervical ripening, before induction of labour, is needed to increase the success of labour induction, to reduce complications and to diminish the rate of caesarean section and duration of labour. Pharmacological preparations are in widespread use for cervical ripening but are not free from side-effects and complications. Mechanical methods, i.e. the use of Foley’s catheter balloon, though effective have not gained much popularity because of the fear of infection. Therefore, the study has been conducted to prove the efficacy and safety of extra amniotic Foley catheter balloon and to compare it with intra-cervical prostaglandin E2 (PGE2) gel. The objective of the study was to the success of induction of labor depends on the cervical status at the time of induction. For effective cervical ripening both Foley's catheter and PGE2 gel are used. The aim of this study was to compare the efficacy of intra cervical Foley's catheter and intra cervical PGE2 gel in cervical ripening for the successful induction of labor.Methods: A randomized, comparative study was conducted in the department of obstetrics and gynaecology, Civil hospital, B.J. Medical College Ahmedabad, during a period of 8 month from September 2018 to April 2019. 100 patients at term with a Bishop's score ≤5 with various indications for induction were randomly allocated to group F (intra-cervical Foley’s catheter) and group P (PGE2 gel) with 50 women included in each group.Results: The groups were comparable with respect to maternal age, gestation age, indication of induction and initial Bishop's score. Both the groups showed significant change in the Bishop's score, 5.10±1.55 and 5.14±1.60 for Foley's catheter and PGE2 gel, respectively, p <0.001. However there was no significant difference between the two groups. There was no significant difference in the side effects and caesarean section rate in both groups. The induction to delivery interval was 16.01±5.50 hours in group F and 16.85 ± 3.81 hours in group P (p=0.073). Apgar scores, birth weights and NICU admissions showed no significant difference between the two groups.Conclusions: The study shows that both Foley's catheter and PGE2 gel are equally effective in pre induction cervical ripening.

scholarly journals Sequential Foley Catheter and Misoprostol Versus Misoprostol Alone for Induction of Labor in Postdated Pregnancy: a Randomized Controlled Trial

2020 ◽  
Vol 3 (1) ◽  
pp. 105-112
Author(s):  
Baburam Dixit Thapa ◽  
Tara Manandhar ◽  
Sarita Sitaula ◽  
Tulasa Basnet
Keyword(s):  
Vaginal Delivery ◽  
Controlled Trial ◽  
Foley Catheter ◽  
Induction Of Labor ◽  
Normal Vaginal Delivery ◽  
Pharmacological Agents ◽  
Sequential Group ◽  
Vaginal Misoprostol ◽  
Foley’S Catheter ◽  
Time To Delivery

Introduction: Induction of labor is done with the aim of normal vaginal delivery. There are different methods; mechanical like intra-cervical Foley’s or pharmacological agents like misoprostol ordinoprostone. Objectives: To compare sequential use of Foley’s catheter and vaginal misoprostol in comparison with vaginal misoprostol only. Methods: Patients with period of gestation more than or equal to 41 weeks without any complications were assigned randomly according to computer generated randomization into sequential use ofintracervical Foley followed by vaginal misoprostol after 24 hours (sequential group) or vaginalmisoprostol only. Primary outcome was rate of normal vaginal delivery. Secondary outcomes were induction to delivery interval, maternal and fetal morbidity. Results: Rate of normal vaginal delivery in sequential group (n= 353) and misoprostol alone group(n= 356) was 71.6% and 53.3% (p < 0.001) but the time to delivery from induction is statistically more in sequential group (30.3 vs. 11.2 hours, p< 0.001). Maternal outcomes like postpartum hemorrhage, hyper-stimulation syndrome, chorioamnitis and neonatal outcomes like low Apgar score, meconium stained baby and stillbirth are similar in both the groups. Conclusions: The priming of cervix using intracervical Foley catheter before giving vaginalmisoprostol was beneficial in increasing the rate of normal vaginal delivery but it increased the induction to delivery interval.

scholarly journals Comparison of low dose vaginal misoprostol with Foley catheter balloon as preinduction cervical ripening agents in term pregnancies

2020 ◽  
Vol 1 ◽  
pp. 10
Author(s):  
Dalyop Davou Nyango ◽  
Daloek M ◽  
Kahansim ML
Keyword(s):  
Pregnant Women ◽  
Low Dose ◽  
Foley Catheter ◽  
Comparative Trial ◽  
Tertiary Hospital ◽  
Cervical Ripening ◽  
Catheter Group ◽  
Misoprostol Group ◽  
Uterine Hyperstimulation ◽  
Vaginal Misoprostol

Objective: One of the obstetricians’ nightmare is managing high-risk pregnancies. Also, the emerging trend by pregnant women requesting for specific delivery dates for social reasons adds to this burden. In both instances, the obstetrician is faced with the challenge of inducing labor where the cervix is still unfavorable. The objective of the study was to compare the effectiveness of loe dose vaginal misoprostol and transcervical extra-amniotic Foley catheter balloon as pre-induction cervical ripening agents in term pregnancies. Material and Methods: This was a prospective, single-blind, randomized comparative trial at a tertiary hospital. Pregnant women at term in whom induction of labor was indicated, who made the inclusion criteria and who gave their consent were randomly assigned to either the vaginal misoprostol or the Foley catheter balloon group. Oxytocin was used for the augmentation of labor subsequent to the artificial rupture of the membranes according to the departmental protocols. Results: One hundred and fifty women were recruited and randomized (75 in each group). In the misoprostol group, 58 (77.3%) women achieved cervical ripening (cervical dilation of ≥4) within 12 h, compared to 43 (57.3%) in the Foley catheter balloon group. Spontaneous vaginal delivery within 12 h was 88.0% and 66.3% in the misoprostol and Foley catheter group, respectively. However, 34.7% in misoprostol group had precipitate labor (induction-to-delivery interval ≤3 h), while 9.3% in the Foley catheter group had prolonged labor. There were no significant differences in the incidence of meconium staining and 1st min Apgar scores of the babies in the two groups. Conclusion: Low dose (25 μg) vaginal misoprostol is a more effective pre-induction cervical ripening agent compared to the conventional transcervical extra-amniotic Foley catheter balloon method. While uterine hyperstimulation is the major risk in the misoprostol group, long induction-to-delivery interval is associated with labors induced following use of Foley catheter balloon as the pre-induction cervical ripening agent.

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