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

Status Suspended

Clinical Trial 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 from 10% to 20.4% in China. The majority of women undergoing labor induction requires cervical ripening for the unfavorable cervixes. As globally, it is still required to explore an optimal induction method. Foley catheter was among the oldest mechanical approaches, while prostaglandin E2 vaginal suppository (PGE2) one of the most popular pharmacological agents for cervical ripening. There were studies reporting similar cesarean section rates between these two methods. However, there are no randomized control trials (RCTs) with adequate power to compare their frequencies of severe perinatal complications. The investigators aim to compare the effectiveness and safety of Foley catheter versus PGE2 for induction of labor among term pregnant women with an unfavourable cervix.

Clinical Trial 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 indication for induction of labor, and a live singleton fetus at cephalic presentation, intact membranes, an unfavorable cervix, no prior cesarean section or contraindication to vaginal delivery, are eligible to participate. After informed consent, they will be randomized to undergo induction of labor by Foley catheter or PGE2. Our primary outcomes will be (I) a composite of severe perinatal complications and (II) vaginal delivery. Before the formal recruitment of this RCT, a pilot study with a sample size of 200 pregnant women will be performed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04780269
Study type	Interventional
Source	Guangzhou Women and Children's Medical Center
Contact
Status	Suspended
Phase	Phase 4
Start date	December 2023
Completion date	December 2024

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See also
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