Perioperative Use of Atosiban for Ultrasound-indicated Ce... | NCT06537778

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

NCT06537778

Sponsor

Children's Hospital of Chongqing Medical University

Status

Completed

Last Update Posted

May 22, 2025Actual

Enrollment

334Actual

Phase

Not Applicable

Conditions

Cervical Cerclage
Premature Birth

Interventions

Atosiban
Normal saline

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2018Actual

Primary Completion Date

Feb 12, 2024Actual

Completion Date

Apr 12, 2024Actual

First Submitted Date

Jul 31, 2024

First Submission Date that Met QC Criteria

Jul 31, 2024

First Posted Date

Aug 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2025

Last Update Posted Date

May 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Li Qin, Principal Investigator, Children's Hospital of Chongqing Medical UniversityPrincipal Investigator

Lead Sponsor

Children's Hospital of Chongqing Medical UniversityOTHER

Collaborators

Name	Class
First Affiliated Hospital of Chongqing Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

334Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
atosiban	Experimental		Drug: Atosiban
normal saline	Placebo Comparator		Drug: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atosiban	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of sPTB	Rate of sPTB before 34 weeks of gestation	up to 34 weeks

Secondary Outcomes

Measure	Description	Time Frame
Rate of preterm delivery <28 or <32 weeks gestation	Rate of preterm delivery <28 or <32 weeks gestation	up to 32 weeks
Gestational latency after cerclage placement (days)	Gestational latency after cerclage placement (days)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women and Children's Hospital of Chongqing Medical University		Chongqing	Chognqing	400016	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Based on the requirements of the ethics committee, the data from this study cannot be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C047046	atosiban
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided