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

Premature Birth Clinical Trial

Official title:

Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth: A Randomized, Double-blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06399965
• Other study ID #: 2017-43
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: April 12, 2024

Study information

• Verified date: May 2024
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: April 12, 2024
• Est. primary completion date: February 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

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.

Related Conditions & MeSH terms

• Cervical Cerclage
• Premature Birth

Intervention

Drug:
• 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 21 h.
• Normal saline
Participants in the placebo group received only normal saline infusion for the same duration as atosiban group.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Women and Children's Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University	Women and Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of sPTB	Rate of sPTB before 34 weeks of gestation	up to 34 weeks
Secondary	Rate of preterm delivery <28 or <32 weeks gestation	Rate of preterm delivery <28 or <32 weeks gestation	up to 32 weeks
Secondary	Gestational latency after cerclage placement (days)	Gestational latency after cerclage placement (days)	through study completion, an average of 1 year
Secondary	Rate of preterm premature rupture of membranes	Rate of preterm premature rupture of membranes	through study completion, an average of 1 year
Secondary	Gestational age at delivery (weeks)	Delivery weeks	through study completion, an average of 1 year