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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
334
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.
Participants in the placebo group received only normal saline infusion for the same duration as atosiban group.
Women and Children's Hospital of Chongqing Medical University
Chongqing, Chognqing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Rate of sPTB
Rate of sPTB before 34 weeks of gestation
Time frame: up to 34 weeks
Rate of preterm delivery <28 or <32 weeks gestation
Rate of preterm delivery \<28 or \<32 weeks gestation
Time frame: up to 32 weeks
Gestational latency after cerclage placement (days)
Gestational latency after cerclage placement (days)
Time frame: through study completion, an average of 1 year
Rate of preterm premature rupture of membranes
Rate of preterm premature rupture of membranes
Time frame: through study completion, an average of 1 year
Gestational age at delivery (weeks)
Delivery weeks
Time frame: through study completion, an average of 1 year
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