Status:

SUSPENDED

Foley Catheter Versus PGE2 for Labor Induction at Term: a Pilot Study

Lead Sponsor:

Guangzhou Women and Children's Medical Center

Conditions:

Labor Induction

Induced Delivery

Eligibility:

FEMALE

18+ years

Phase:

PHASE4

Brief Summary

Induction of labor is one of the most common interventions in obstetrics. In the past decade, the rates of labor induction at term have doubled from approximately 9% to 23% in the United States and fr...

Detailed Description

The investigators propose a single center, open-label, randomized controlled clinical trial (1:1 treatment ratio) in Guangzhou Women and Children's Medical Center. Women with a term pregnancy, an indi...

Eligibility Criteria

Inclusion

  • Women scheduled for induction of labor.
  • Women aged ≥ 18 years old
  • ≥ 37 weeks of gestation
  • Live singleton pregnancy in cephalic presentation
  • Intact membranes
  • Cervical Bishop score \< 6
  • Informed consent.

Exclusion

  • Contraindications for vaginal delivery.
  • Prior cesarean section
  • Known hypersensitivity for Foley catheter or PGE2
  • Non-reassuring fetal status
  • Lethal fetal congenital anomaly

Key Trial Info

Start Date :

December 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04780269

Start Date

December 1 2023

End Date

December 1 2024

Last Update

September 15 2023

Active Locations (1)

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Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China, 510623