Preterm BirthPhase 4NCT05061641
Prediction and Prevention of Twin Premature Birth 2021
A Phase 4 study testing Progesterone in people with Preterm Birth, run by Caixia Liu at 1 site in China.
Trial summary
Research Objectives: 1. Establish a prediction and scoring system for twin premature birth. 2. To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth. 3. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Progesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Jun 2022
- Phase
- Phase 4
- 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- twins with cervical length ≤ 25 mm by vaginal ultrasound at 14-32 weeks no contractions, abdominal pain and vaginal bleeding No complicated twin complications occurred during pregnancy
Who cannot join
- Patients undergoing selective cervical ligation before 14 weeks of gestation history of liver problems or cholestasis during pregnancy Abnormal liver enzymes Abnormal renal function Local allergy to trace natural progesterone Recurrent vaginal bleeding Recurrent vaginal infection Ultrasound diagnosis of fetal abnormality Intrauterine treatment for fetal abnormalities
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
caixia Liu
Shenyang, Liaoning, 110001
Liu caixia, professor, 86-024-96615 ext. 10027, 18940252882@163.com
About this study
Official title: Study on the Prediction and Prevention of Twin Premature Birth
Research Objectives:
- Establish a prediction and scoring system for twin premature birth.
- To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
- To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
- The optimal dose of atosiban for the treatment of twin premature birth.
- The influence of delivery mode on twin premature infants under 32 weeks.
Read the detailed description
Research Objectives:
- Establish a prediction and scoring system for twin premature birth.
- To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
- To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
- The optimal dose of atosiban for the treatment of twin premature birth.
- The influence of delivery mode on twin premature infants under 32 weeks. It has now entered the second phase: clinical data collection
- Conditions
- Preterm Birth
- Being tested
- Progesterone
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Also called surgical treatment
The delivery outcomes of the three groups were compared, including the rate of premature delivery (<37 weeks of gestation), the rate of early premature delivery (<32 weeks of gestation), and the need for anti-tocolysis treatment. Rates of premature rupture of membranes (<37 weeks), neonatal perinatal mortality and morbidity.
| Study group | Role | What they receive |
|---|---|---|
| progesterone 200mg | Active comparator | Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 200mg Receives: Drug: Progesterone |
| progesterone 400mg | Experimental | Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 400mg Receives: Drug: Progesterone |
| progesterone 600mg | Experimental | Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 600mg Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal prognosis
Preterm birth rate (<37 weeks of gestation), early preterm birth rate (<32 weeks of gestation), need to receive anti-tocolytic treatment; Rates of premature rupture of membranes (<37 weeks), neonatal perinatal mortality and morbidity.
Measured: one week
Secondary outcomes (1)
Gestational age and prolongation of gestational age at delivery
Gestational age at which symptoms of preterm birth occur and gestational age at delivery after treatment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 May 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective cohort study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caixia Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caixia Liu, Shengjing Hospital
- Investigators
- Wei jun, Dr, Study chair, 1050880483@qq.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061641
- Sponsor's protocol ID
- TPB 2021
- Status last verified
- Sep 2021
- First submitted
- 26 Jun 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Prediction and Prevention of Twin Premature Birth
- ClinicalTrials.gov ID
- NCT05061641
- Acronym / sponsor ID
- TPB 2021
- Conditions
- Preterm Birth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Caixia LiuUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 29 Sep 2021 (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.
Research Objectives:
- Establish a prediction and scoring system for twin premature birth.
- To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
- To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
- The optimal dose of atosiban for the treatment of twin premature birth.
- The influence of delivery mode on twin premature infants under 32 weeks.
Detailed description
Research Objectives:
- Establish a prediction and scoring system for twin premature birth.
- To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
- To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
- The optimal dose of atosiban for the treatment of twin premature birth.
- The influence of delivery mode on twin premature infants under 32 weeks. It has now entered the second phase: clinical data collection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| progesterone 200mg | Active comparator | Drug: ProgesteroneEach group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 200mg |
| progesterone 400mg | Experimental | Drug: ProgesteroneEach group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 400mg |
| progesterone 600mg | Experimental | Drug: ProgesteroneEach group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 600mg |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- twins with cervical length ≤ 25 mm by vaginal ultrasound at 14-32 weeks no contractions, abdominal pain and vaginal bleeding No complicated twin complications occurred during pregnancy
Key exclusion criteria (1 listed)
- Patients undergoing selective cervical ligation before 14 weeks of gestation history of liver problems or cholestasis during pregnancy Abnormal liver enzymes Abnormal renal function Local allergy to trace natural progesterone Recurrent vaginal bleeding Recurrent vaginal infection Ultrasound diagnosis of fetal abnormality Intrauterine treatment for fetal 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 |
|---|---|---|
| ProgesteroneAlso: surgical treatmentThe delivery outcomes of the three groups were compared, including the rate of premature delivery (<37 weeks of gestation), the rate of early premature delivery (<32 weeks of gestation), and the need for anti-tocolysis treatment. Rates of premature rupture of membranes (<37 weeks), neonatal perinatal mortality and morbidity. | Drug | progesterone 200mg, progesterone 400mg, progesterone 600mg |
Primary outcome
Neonatal prognosis
Time frame: one week
Preterm birth rate (<37 weeks of gestation), early preterm birth rate (<32 weeks of gestation), need to receive anti-tocolytic treatment; Rates of premature rupture of membranes (<37 weeks), neonatal perinatal mortality and morbidity.
1 secondary outcome
Gestational age and prolongation of gestational age at delivery
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Wei jun, Dr study chair
1050880483@qq.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progesterone in people with Preterm Birth, run by Caixia Liu at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu caixia, Dr (18940251716, liucx1716@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal prognosis (time frame: one week). 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 29 Sep 2021.