Comparing Foley Catheter Balloon With Early Amniotomy for Induction of Labor at Term

• ClinicalTrials.gov Identifier: NCT03629548
• Recruitment Status: Completed
• First Posted: August 14, 2018
• Last Update Posted: February 4, 2021
• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Information provided by (Responsible Party): Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Study Description

Brief Summary:

This study evaluates the intervention for induction of labor with low bishop scores . One group will be induced by transcervical Foley catheter balloon and vaginal PGE2 and other group will be induced by early amniotomy and PGE2 vaginal ovule for induction of labor at term.

Condition or disease	Intervention/treatment	Phase
Induced Vaginal Delivery	Procedure: early amniotomy; Device: foley catheter balloon placement	Not Applicable

Detailed Description:

An unfavorable cervix during induction decreases the success rate of labor induction and vaginal delivery. Therefore it is required to apply cervical ripening methods for unfavorable cervices. Application of transcervical Foley catheter is an effective mechanical method and has the advantages of lower cost and lowest rate of fetal heart rate changes due to tachysystole compared with PGE1 and PGE2. Despite the advantages of mechanical methods, PGE1 and PGE2 are reported to be more effective than mechanical methods to achieve vaginal delivery within 24 hours. Although there are a lot of studies comparing PGE1, PGE2 and transcervical Foley balloon catheter separately and PGE1 combined with transcervical Foley balloon catheter, less is known about combined usage of PGE2 and transcervical Foley balloon catheter. Early amniotomy is another effective method to ripen cervix. we aim to evaluate which method is superior to another.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparing Combined Foley Catheter Balloon and PGE2 Vaginal Ovule With Early Amniotomy and PGE2 for Induction of Labor at Term: A Randomized Study
• Actual Study Start Date: August 15, 2018
• Actual Primary Completion Date: September 15, 2019
• Actual Study Completion Date: October 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: early amniotomy plus dinoprostone; 10 mg dinoprostone vaginal ovul will be inserted to the posterior fornix. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook.	Procedure: early amniotomy; 10 mg PGE2 vaginal ovul will be inserted to the posterior fornix. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook.
Experimental: foley balloon catheter plus dinoprostone; an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix and after placement of balloon catheter 10 mg dinoprostone vaginal ovul will be inserted to the posterior fornix	Device: foley catheter balloon placement; an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix and after placement of balloon catheter 10 mg PGE2 vaginal ovul will be inserted to the posterior fornix; Other Name: mechanic and medical method

Outcome Measures

Primary Outcome Measures :

1. induction-to- delivery time [ Time Frame: from the beginning of induction until the labor ]
   the length of time between the beginning of induction and the end of labor

Secondary Outcome Measures :

1. induction-to-active phase of labor time [ Time Frame: from the beginning of induction until the labor ]
   the length of time between the beginning of induction and the onset of labor

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: term pregnancies
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. singleton pregnancy,
2. gestational age ≥37 weeks,
3. intact membranes,
4. cephalic presentation,
5. bishop score ≤5,
6. had obstetrical indications for induction of labor,
7. had less than three uterine contractions in every 10 minutes.

Exclusion Criteria:

1. Patients who had contraindications for vaginal delivery,
2. previous uterine surgery,
3. fetal malpresentation,
4. multifetal pregnancy,
5. more than three contractions in 10 minutes,
6. contraindications to prostaglandins,

Contacts and Locations

Locations

Turkey

Zeynep Kamil Education and Research Hospital

Istanbul, Uskudar, Turkey, 34668

Sponsors and Collaborators

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Investigators

• Study Director: ahmet eser, M.D.; Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey

More Information

• Responsible Party: Ahmet Eser, Principal investigator, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• ClinicalTrials.gov Identifier: NCT03629548
• Other Study ID Numbers: 48
• First Posted: August 14, 2018
• Last Update Posted: February 4, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital:

dinoprostone; early amniotomy; labor induction; foley bulb