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

Induced Vaginal Delivery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629548
• Other study ID #: 48
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: February 2021
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 1, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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,

Related Conditions & MeSH terms

• Induced Vaginal Delivery

Intervention

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.

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

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Education and Research Hospital	Istanbul	Uskudar

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	induction-to- delivery time	the length of time between the beginning of induction and the end of labor	from the beginning of induction until the labor
Secondary	induction-to-active phase of labor time	the length of time between the beginning of induction and the onset of labor	from the beginning of induction until the labor