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

NCT06537778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2025-05-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • First Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • Children's Hospital of Chongqing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2024-02-12
Completion
2024-04-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06537778 on ClinicalTrials.gov