Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT04780269
Status:
SUSPENDED
Last Update Posted:
2023-09-15
First Post:
2021-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Foley Catheter Versus PGE2 for Labor Induction at Term: a Pilot Study
Sponsor:
Guangzhou Women and Children's Medical Center
Organization:
Study Overview
Official Title:
Foley Catheter Versus Prostaglandin E2 Vaginal Suppository for Labor Induction at Term: a Pilot Study
Status:
SUSPENDED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
understaffed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: