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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2024-04-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Cerclage Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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atosiban

Group Type EXPERIMENTAL

Atosiban

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes