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

Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth: A Randomized, Double-blind Clinical Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Premature Birth; Cervical Cerclage
• Intervention / Treatment: Drug: Atosiban; Drug: Normal saline

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China, 400016
      • Women and Children's Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: normal saline	Drug: Normal saline; Participants in the placebo group received only normal saline infusion for the same duration as atosiban group.
Experimental: atosiban	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 21 h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of sPTB	Rate of sPTB before 34 weeks of gestation	up to 34 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University
• Collaborators: Chongqing Medical Center for Women and Children

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): February 12, 2024
• Study Completion (Actual): April 12, 2024

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Reproductive Control Agents; Tocolytic Agents; Atosiban
• Other Study ID Numbers: 2017-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Based on the requirements of the ethics committee, the data from this study cannot be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No