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

NCT ID: NCT04780269

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2024-12-31

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.

Conditions

Labor Induction; Induced Delivery

Study Design

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

Study Groups

Induction of labor with Foley catheter

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

Group Type: EXPERIMENTAL

Induction of labor with Foley catheter

Intervention Type: DEVICE

A Foley catheter will be introduced transcervically in women allocated in this group, with the aid of a vaginal speculum after cervical cleaning with an aseptic solution. The balloon will be inflated with 60 mL of sterile 0.9%% sodium chloride (NaCl) after insertion past the internal os. The external end of the catheter is taped to the inner thigh without applying any traction or tension.

Induction of labor with PGE2

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

Group Type: EXPERIMENTAL

Induction of labor with PGE2

Intervention Type: DRUG

PGE2 (1mg) will be inserted into the posterior vaginal fornix. Women will be assigned one hour of bed rest while continuously monitored by cardiotocography.

Interventions

Induction of labor with Foley catheter

A Foley catheter will be introduced transcervically in women allocated in this group, with the aid of a vaginal speculum after cervical cleaning with an aseptic solution. The balloon will be inflated with 60 mL of sterile 0.9%% sodium chloride (NaCl) after insertion past the internal os. The external end of the catheter is taped to the inner thigh without applying any traction or tension.

Intervention Type: DEVICE

Induction of labor with PGE2

PGE2 (1mg) will be inserted into the posterior vaginal fornix. Women will be assigned one hour of bed rest while continuously monitored by cardiotocography.

Intervention Type: DRUG

Other Intervention Names

Foley Catheter; Dinoprostone suppositories

Eligibility Criteria

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

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

Sponsors

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Zehong Zhou

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JinYing Yang, MD.

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Women and Children's Medical Center

Locations

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Countries

China

References

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Reference Type: BACKGROUND

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Other Identifiers

[2020]31201

Identifier Type: -

Identifier Source: org_study_id