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

NCT06537778 | Completed

• 1 other identifier: 2017-043
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervical Cerclage; Premature Birth

Outcome Measures

Primary Outcomes (1)

• Rate of sPTB

  Rate of sPTB before 34 weeks of gestation

  up to 34 weeks

Secondary Outcomes (4)

• Rate of preterm delivery <28 or <32 weeks gestation

  up to 32 weeks

• Gestational latency after cerclage placement (days)

  through study completion, an average of 1 year

• Rate of preterm premature rupture of membranes

  through study completion, an average of 1 year

• Gestational age at delivery (weeks)

  through study completion, an average of 1 year

Study Arms (2)

atosiban

EXPERIMENTAL

Drug: Atosiban

normal saline

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

Atosiban DRUG

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.

atosiban

Normal saline DRUG

Participants in the placebo group received only normal saline infusion for the same duration as atosiban group.

normal saline

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University: lead
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (2)

Women and Children's Hospital of Chongqing Medical University

Chongqing, Chognqing, 400016, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

MeSH Terms

Conditions

Premature Birth

Interventions

atosiban; Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: January 3, 2018
• Primary Completion: February 12, 2024
• Study Completion: April 12, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)