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

Chongqing Medical University

Status

Completed

Conditions

Cervical Cerclage

Premature Birth

Treatments

Drug: Atosiban

Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT06537778

2017-043

Details and patient eligibility

About

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.

Enrollment

334 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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.