Twin Pregnancy With Antenatal ProblemPhase 4NCT04748562
Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies
A Phase 4 study testing Progesterone in people with Twin Pregnancy With Antenatal Problem, run by Ain Shams University at 1 site in Egypt.
Trial summary
It is already known that the risk of preterm labor in twin pregnancy before 37 week is 8-9 fold higher compared to singletons, and progesterone supplementation can decrease the incidence of preterm labor in singleton pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Twin Pregnancy With Antenatal Problem
- What is being tested?
- Progesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Dec 2020
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primigravidae
- Twin pregnancies at gestational age 14 week.
- Cervical length more than 2 cm (because if 2cm or less they will undergo cervical cerclage.)
Who cannot join
- Polyhydramnios
- Anemia
- Twins with congenital malformation
- Twin to twin transfusion
- Medical diseases as diabetes mellitus, hypertension and systemic lupus erythematosis
- Previous cervical surgery
- High order pregnancy (triples or more)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies: a Randomised Controlled Trial
It is already known that the risk of preterm labor in twin pregnancy before 37 week is 8-9 fold higher compared to singletons, and progesterone supplementation can decrease the incidence of preterm labor in singleton pregnancy.
There were studies that used 200mg vaginal progesterone with no effect on the result So this study aims To examine the effect of prophylactic vaginal progesterone 400mg v.s 200mg for prevention of preterm birth in twin pregnancies
- Conditions
- Twin Pregnancy With Antenatal Problem
- Being tested
- Progesterone
- Keywords
- Progesterone, Twin pregnancy, Preterm labor
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Taking prontogest vaginally
| Study group | Role | What they receive |
|---|---|---|
| 400 mg progesterone group | Active comparator | Taking 400 mg vaginal progesterone Receives: Drug: Progesterone |
| 200 mg progesterone group | Active comparator | Taking 200 mg vaginal progesterone Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm labor
Number of participants which had preterm labor
Measured: Before 37 weeks gestation
Secondary outcomes (4)
Cervical length changes
Cervical length changes in centimeters
Measured: Between 14 weeks and 22 weeks gestation
Neonatal ICU admission
Number of neonates required neonatal ICU admission
Measured: The first 28 days after delivery
Neonatal mechanical ventilation
Number of neonates required mechanical ventilation
Measured: The first 28 days after delivery
Progesterone side effects
The number of patients experiencing progesterone side effects
Measured: During one year which is the period from the start of the study till its end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Jan 2020
- Primary completion1 Aug 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Pregnancy With Antenatal ProblemStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748562
- Sponsor's protocol ID
- MS 483/2019
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04748562
- Acronym / sponsor ID
- MS 483/2019
- Conditions
- Twin Pregnancy With Antenatal Problem
- Keywords
- Progesterone, Twin pregnancy, Preterm labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 10 Feb 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.
It is already known that the risk of preterm labor in twin pregnancy before 37 week is 8-9 fold higher compared to singletons, and progesterone supplementation can decrease the incidence of preterm labor in singleton pregnancy.
There were studies that used 200mg vaginal progesterone with no effect on the result So this study aims To examine the effect of prophylactic vaginal progesterone 400mg v.s 200mg for prevention of preterm birth in twin pregnancies
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 400 mg progesterone group | Active comparator | Drug: ProgesteroneTaking 400 mg vaginal progesterone |
| 200 mg progesterone group | Active comparator | Drug: ProgesteroneTaking 200 mg vaginal progesterone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primigravidae
- Twin pregnancies at gestational age 14 week.
- Cervical length more than 2 cm (because if 2cm or less they will undergo cervical cerclage.)
Key exclusion criteria (7 listed)
- Polyhydramnios
- Anemia
- Twins with congenital malformation
- Twin to twin transfusion
- Medical diseases as diabetes mellitus, hypertension and systemic lupus erythematosis
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 |
|---|---|---|
| ProgesteroneTaking prontogest vaginally | Drug | 200 mg progesterone group, 400 mg progesterone group |
Primary outcome
Preterm labor
Time frame: Before 37 weeks gestation
Number of participants which had preterm labor
4 secondary outcomes
Cervical length changes
Time frame: Between 14 weeks and 22 weeks gestation
Neonatal ICU admission
Time frame: The first 28 days after delivery
Neonatal mechanical ventilation
Time frame: The first 28 days after delivery
Progesterone side effects
Time frame: During one year which is the period from the start of the study till its end
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 10 Feb 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Twin Pregnancy With Antenatal Problem
Active, not recruitingObservational study
Twin Pregnancy Cohort
Pregnant With Complication, Twin Pregnancy With Antenatal Problem
RecruitingObservational study
Twin Pregnancy: a Challenge for Patients, Families and Health Professionals
Twin Pregnancy With Antenatal Problem, Twin Diseases
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.
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 Twin Pregnancy With Antenatal Problem, run by Ain Shams University at 1 site in Egypt.
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 10 Feb 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 Egypt. 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?
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?
Preterm labor (time frame: Before 37 weeks gestation). 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 10 Feb 2021.