NCT06537778

Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth(sPTB)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Children's Hospital of Chongqing Medical University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

After ultrasound-indicated cerclage, some pregnant women still experience sPTB, and there is controversy regarding the use of tocolytic agents during the perioperative period to reduce the incidence of sPTB. In this study, the investigators employed a randomized double-blind method to investigate whether the use of atosiban during the perioperative period can reduce the incidence of sPTB before 34 weeks.

Conditions

• Cervical Cerclage
• Premature Birth

Interventions

Type	Name	Description
DRUG	Atosiban	Women in the atosiban group received i.v. atosiban (Manufacturer: Pfizer, Germany) 30 min before the surgery with a bolus dose of 6.75 mg, and the infusion was continued with an infusion rate of 18 mg/h for 3 h. The dose of atosiban was then reduced to 6 mg/h for another 45 h.
DRUG	Normal saline	Participants in the placebo group received only normal saline infusion for the same duration as atosiban group.

Timeline

• Start date: 2018-01-03
• Primary completion: 2024-02-12
• Completion: 2024-04-12
• First posted: 2024-08-05
• Last updated: 2025-05-22

Locations

2 sites across 1 country: China