Twin; Pregnancy, Affecting Fetus or NewbornNCT03781674
Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation
A study testing progesterone 400mg and progesterone 200mg in people with Twin; Pregnancy, Affecting Fetus or Newborn, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
The objective of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Twin; Pregnancy, Affecting Fetus or Newborn
- What is being tested?
- progesterone 400mg and progesterone 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Mar 2022
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women pregnant in dichorionic twins.
- Transvaginal sonographic cervical length is <25 mm at 18-22 weeks gestational age.
- No symptoms, signs or other risk factors for preterm labor.
Who cannot join
- Known allergy or contraindication (relative or absolute) to progesterone therapy.
- Monochorionic twins.
- Known major fetal structural or chromosomal abnormality.
- Intrauterine death of one fetus or death of both fetuses.
- Fetal reduction in the current pregnancy.
- Cervical cerclage in the current pregnancy.
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- Medical conditions that may lead to preterm delivery.
- Rupture of membranes.
- Vaginal bleeding.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University
Aswān, 81528
hany f sallam, md, 01092440504 ext. 002, nahla.elsayed@aswu.ed.eg
Nahla w Shady, md, 1019240504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
Official title: Evaluation of the Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation With Short Cervix: a Double-Blind Randomized Controlled Trial
The objective of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
Read the detailed description
The use of progesterone in the prevention of preterm birth(PTB) in both singleton and multiple pregnancies has been extensively investigated. Arguably, the use of progesterone is biologically plausible given that uterine quiescence is maintained throughout pregnancy by progesterone and progesterone receptor-mediated inhibition of inflammation, which causes suppression of the contractile genes. There is no benefit of universal vaginal progesterone to reduce PTB rates in multiple pregnancies. One meta-analysis showed a benefit in adverse perinatal outcome in a subgroup of women with a short cervix ≤25 mm, suggesting it may be useful in this group, but the numbers in the study were small and further research is needed. There appears to be no long-term harm caused to infants exposed to progesterone in utero. So the aim of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome
- Being tested
- progesterone 400mg, progesterone 200mg, placebo to progesterone 200mg, placebo to progesterone 400mg
- Keywords
- Preterm birth, Twin gestation, Vaginal 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.
progesterone 400mgDrug
Also called Active Comparator
Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age
progesterone 200mgDrug
Also called Active Comparator
Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age
placebo to progesterone 200mgDrug
Also called Placebo comparator
Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age
placebo to progesterone 400mgDrug
Also called placebo comparator
Women received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age
| Study group | Role | What they receive |
|---|---|---|
| progesterone 400mg | Active comparator | Women received vaginal progesterone suppositories in a dose of 400 mg(4 tablets) daily beginning at 18-22 weeks gestational age Receives: Drug: progesterone 400mg |
| progesterone 200mg plus placebo to progesterone 200 mg | Active comparator | Women received vaginal progesterone suppositories in a dose of 200 mg(2 tablets) daily beginning at 18-22 weeks gestational age plus 2tablets placebo to vaginal progesterone Receives: Drug: progesterone 200mg; Drug: placebo to progesterone 200mg |
| placebo to progesterone 400 mg | Placebo comparator | Women received 4 tablets placebo to vaginal progesterone suppositories Receives: Drug: placebo to progesterone 200mg; Drug: placebo to progesterone 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm labor before 34 weeks gestations
Number of patients delivered before 34 weeks gestations
Measured: Up to 34 weeks gestational age
Secondary outcomes (1)
Neonatal respiratory distress syndrome
Number of neonates develop respiratory distress syndrome
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin; Pregnancy, Affecting Fetus or NewbornStudies 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
- Model description
- a double-blind randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781674
- Sponsor's protocol ID
- aswu/194/18
- Status last verified
- Feb 2019
- First submitted
- 18 Dec 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- 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 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation With Short Cervix: a Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03781674
- Acronym / sponsor ID
- aswu/194/18
- Keywords
- Preterm birth, Twin gestation, Vaginal progesterone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 20 Dec 2018 (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.
The objective of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
Detailed description
The use of progesterone in the prevention of preterm birth(PTB) in both singleton and multiple pregnancies has been extensively investigated. Arguably, the use of progesterone is biologically plausible given that uterine quiescence is maintained throughout pregnancy by progesterone and progesterone receptor-mediated inhibition of inflammation, which causes suppression of the contractile genes. There is no benefit of universal vaginal progesterone to reduce PTB rates in multiple pregnancies. One meta-analysis showed a benefit in adverse perinatal outcome in a subgroup of women with a short cervix ≤25 mm, suggesting it may be useful in this group, but the numbers in the study were small and further research is needed. There appears to be no long-term harm caused to infants exposed to progesterone in utero. So the aim of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- a double-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| progesterone 400mg | Active comparator | Drug: progesterone 400mgWomen received vaginal progesterone suppositories in a dose of 400 mg(4 tablets) daily beginning at 18-22 weeks gestational age |
| progesterone 200mg plus placebo to progesterone 200 mg | Active comparator | Drug: progesterone 200mg, Drug: placebo to progesterone 200mgWomen received vaginal progesterone suppositories in a dose of 200 mg(2 tablets) daily beginning at 18-22 weeks gestational age plus 2tablets placebo to vaginal progesterone |
| placebo to progesterone 400 mg | Placebo comparator | Drug: placebo to progesterone 200mg, Drug: placebo to progesterone 400mgWomen received 4 tablets placebo to vaginal progesterone suppositories |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women pregnant in dichorionic twins.
- Transvaginal sonographic cervical length is <25 mm at 18-22 weeks gestational age.
- No symptoms, signs or other risk factors for preterm labor.
Key exclusion criteria (9 listed)
- Known allergy or contraindication (relative or absolute) to progesterone therapy.
- Monochorionic twins.
- Known major fetal structural or chromosomal abnormality.
- Intrauterine death of one fetus or death of both fetuses.
- Fetal reduction in the current pregnancy.
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 |
|---|---|---|
| progesterone 400mgAlso: Active ComparatorWomen received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age | Drug | progesterone 400mg |
| progesterone 200mgAlso: Active ComparatorWomen received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age | Drug | progesterone 200mg plus placebo to progesterone 200 mg |
| placebo to progesterone 200mgAlso: Placebo comparatorWomen received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age | Drug | placebo to progesterone 400 mg, progesterone 200mg plus placebo to progesterone 200 mg |
| placebo to progesterone 400mgAlso: placebo comparatorWomen received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age | Drug | placebo to progesterone 400 mg |
Primary outcome
Preterm labor before 34 weeks gestations
Time frame: Up to 34 weeks gestational age
Number of patients delivered before 34 weeks gestations
1 secondary outcome
Neonatal respiratory distress syndrome
Time frame: At birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
hany f sallam, md principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progesterone 400mg and progesterone 200mg in people with Twin; Pregnancy, Affecting Fetus or Newborn, run by Aswan University Hospital 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 9 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 15 Feb 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hany f sallam, md (01022336052 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm labor before 34 weeks gestations (time frame: Up to 34 weeks gestational age). 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 15 Feb 2019.