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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Guangzhou Women and Children's Medical Center
• Treatments: Dinoprostone

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