Status
Completed
Phase
Not applicable
Enrollment
334
Locations
2
Results
Not posted
Publications
0
Study 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.
Interventions
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.
DRUG
Participants in the placebo group received only normal saline infusion for the same duration as atosiban group.
Timeline
First posted
Aug 5, 2024
Study start
Jan 3, 2018
Primary completion
Feb 12, 2024
Study completion
Apr 12, 2024
Results posted
Not reported
Registry updated
May 22, 2025
Outcomes
Rate of sPTB
Time frame · up to 34 weeks
Rate of sPTB before 34 weeks of gestation
Rate of preterm delivery <28 or <32 weeks gestation
Time frame · up to 32 weeks
Rate of preterm delivery \<28 or \<32 weeks gestation
Gestational latency after cerclage placement (days)
Time frame · through study completion, an average of 1 year
Gestational latency after cerclage placement (days)
Rate of preterm premature rupture of membranes
Time frame · through study completion, an average of 1 year
Rate of preterm premature rupture of membranes
Gestational age at delivery (weeks)
Time frame · through study completion, an average of 1 year
Delivery weeks
Eligibility
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 locations
China. Showing up to 24 locations stored in the fast local snapshot.
Women and Children's Hospital of Chongqing Medical University
Chongqing, Chognqing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Publications
No PMID-linked publications were present in this registry snapshot.
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