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

Not Applicable

Completed

• Conditions: Premature Birth; Cervical Cerclage
• Interventions: Drug: Atosiban; Drug: Normal saline

• Registration Number: NCT06537778
• Lead Sponsor: Children's Hospital of Chongqing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Primary Completion: 2024-02-12
• Study Completion: 2024-04-12
• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 334

Inclusion Criteria

• (i) Viable singleton gestation between 14 0/7 and 23 6/7 weeks of gestation.
• (ii) Previous history of miscarriage or preterm labor in mid-pregnancy.
• (iii) Transvaginal ultrasound examination showed that the cervix is 25mm or less at gestations less than 24 weeks.

Exclusion Criteria

• (i) Women with uterine contractions.
• (ii) Vaginal bleeding.
• (iii) Symptoms of chorioamnionitis.
• (iv) Medically indicated PTB (severe preeclampsia, placental abruption, preterm premature rupture of membranes).
• (v) Major structural or chromosomal abnormalities.
• (vi) Contraindication to atosiban.
• (vii) Had received atosiban or any tocolytic agents within 7 days before their presentation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atosiban	Atosiban	-
normal saline	Normal saline	-

Primary Outcome Measures

Name	Time	Method
Rate of sPTB	up to 34 weeks	Rate of sPTB before 34 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Rate of preterm premature rupture of membranes	through study completion, an average of 1 year	Rate of preterm premature rupture of membranes
Gestational latency after cerclage placement (days)	through study completion, an average of 1 year	Gestational latency after cerclage placement (days)
Rate of preterm delivery <28 or <32 weeks gestation	up to 32 weeks	Rate of preterm delivery \<28 or \<32 weeks gestation
Gestational age at delivery (weeks)	through study completion, an average of 1 year	Delivery weeks

Trial Locations

Locations (2)

Women and Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chognqing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China