Cervical Cerclage, Premature Birth
Conditions
Brief 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
DRUGAtosiban
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.
DRUGNormal saline
Participants in the placebo group received only normal saline infusion for the same duration as atosiban group.
Sponsors
First Affiliated Hospital of Chongqing Medical University
Children's Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of sPTB | up to 34 weeks | Rate of sPTB before 34 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of preterm delivery <28 or <32 weeks gestation | up to 32 weeks | Rate of preterm delivery \<28 or \<32 weeks gestation |
| Gestational latency after cerclage placement (days) | through study completion, an average of 1 year | Gestational latency after cerclage placement (days) |
| Rate of preterm premature rupture of membranes | through study completion, an average of 1 year | Rate of preterm premature rupture of membranes |
| Gestational age at delivery (weeks) | through study completion, an average of 1 year | Delivery weeks |
Countries
China
Outcome results
None listed