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

NCT ID: NCT03629548

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2019-10-01

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.

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.

Conditions

Induced Vaginal Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

early amniotomy

Intervention Type: PROCEDURE

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.

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

Group Type: EXPERIMENTAL

foley catheter balloon placement

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: DEVICE

Other Intervention Names

mechanic and medical method

Eligibility 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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmet Eser

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ahmet eser, M.D.

Role: STUDY_DIRECTOR

Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey

Locations

Zeynep Kamil Education and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

Reference Type: DERIVED

PMID: 36996264 (View on PubMed)

Other Identifiers

48

Identifier Type: -

Identifier Source: org_study_id