Skip to main content
OpenTrials
Completed

NCT Number: NCT06537778

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Cerclage Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

normal saline

Drug

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

Primary outcomes

  1. Rate of sPTB

    Time frame: up to 34 weeks

    Rate of sPTB before 34 weeks of gestation

Secondary outcomes

  1. Rate of preterm delivery <28 or <32 weeks gestation

    Time frame: up to 32 weeks

    Rate of preterm delivery <28 or <32 weeks gestation

  2. Gestational latency after cerclage placement (days)

    Time frame: through study completion, an average of 1 year

    Gestational latency after cerclage placement (days)

  3. Rate of preterm premature rupture of membranes

    Time frame: through study completion, an average of 1 year

    Rate of preterm premature rupture of membranes

  4. Gestational age at delivery (weeks)

    Time frame: through study completion, an average of 1 year

    Delivery weeks

Sponsors and collaborators

Lead sponsor

Children's Hospital of Chongqing Medical University

Other

Collaborators

  • First Affiliated Hospital of Chongqing Medical University

Registry information

Acronym: sPTB

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.