Cervical CerclagesPTBNCT06537778
Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth(sPTB)
A study testing Atosiban and Normal saline in people with Cervical Cerclage and Premature Birth, run by Children's Hospital of Chongqing Medical University at 2 sites in China.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cerclage, Premature Birth
- What is being tested?
- Atosiban and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 2 sitesChina
- Study dates
- 3 Jan 2018to 12 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Women and Children's Hospital of Chongqing Medical University
Chongqing, Chognqing, 400016
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
About this study
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.
- Conditions
- Cervical Cerclage, Premature Birth
- Being tested
- Atosiban, Normal saline
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtosibanDrug
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.
Normal salineDrug
Participants in the placebo group received only normal saline infusion for the same duration as atosiban group.
| Study group | Role | What they receive |
|---|---|---|
| atosiban | Experimental | Not described Receives: Drug: Atosiban |
| normal saline | Placebo comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sPTB
Rate of sPTB before 34 weeks of gestation
Measured: up to 34 weeks
Secondary outcomes (4)
Rate of preterm delivery <28 or <32 weeks gestation
Rate of preterm delivery <28 or <32 weeks gestation
Measured: up to 32 weeks
Gestational latency after cerclage placement (days)
Gestational latency after cerclage placement (days)
Measured: through study completion, an average of 1 year
Rate of preterm premature rupture of membranes
Rate of preterm premature rupture of membranes
Measured: through study completion, an average of 1 year
Gestational age at delivery (weeks)
Delivery weeks
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start3 Jan 2018
- Primary completion12 Feb 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CerclageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Qin, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537778
- Sponsor's protocol ID
- 2017-043
- Acronym
- sPTB
- Status last verified
- May 2025
- First submitted
- 31 Jul 2024
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on the requirements of the ethics committee, the data from this study cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth(sPTB)
- ClinicalTrials.gov ID
- NCT06537778
- Acronym / sponsor ID
- sPTB / 2017-043
- Conditions
- Cervical Cerclage, Premature Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Chongqing Medical University
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atosiban | Experimental | Drug: Atosiban |
| normal saline | Placebo comparator | Drug: Normal saline |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (7 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtosibanWomen 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. | Drug | atosiban |
| Normal salineParticipants in the placebo group received only normal saline infusion for the same duration as atosiban group. | Drug | normal saline |
Primary outcome
Rate of sPTB
Time frame: up to 34 weeks
Rate of sPTB before 34 weeks of gestation
4 secondary outcomes
Rate of preterm delivery <28 or <32 weeks gestation
Time frame: up to 32 weeks
Gestational latency after cerclage placement (days)
Time frame: through study completion, an average of 1 year
Rate of preterm premature rupture of membranes
Time frame: through study completion, an average of 1 year
Gestational age at delivery (weeks)
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No. Based on the requirements of the ethics committee, the data from this study cannot be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atosiban and Normal saline in people with Cervical Cerclage and Premature Birth, run by Children's Hospital of Chongqing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of sPTB (time frame: up to 34 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.