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

Guangzhou Women and Children's Medical Center

Status and phase: Suspended; Phase 4

Conditions: Labor Induction; Induced Delivery

Treatments: Device: Induction of labor with Foley catheter; Drug: Induction of labor with PGE2

Study type: Interventional

Funder types: Other

Identifiers

NCT04780269

[2020]31201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Induction of labor with Foley catheter

Experimental group

Description:

A Foley catheter will be introduced transcervically in women allocated in this group.

Treatment:

Device: Induction of labor with Foley catheter

Induction of labor with PGE2

Experimental group

Description:

PGE2 (1mg) will be inserted into the posterior vaginal fornix.

Treatment:

Drug: Induction of labor with PGE2