Preterm BirthPhase 3NCT02697331
Vaginal Progesterone in Twin With Short Cervix
A Phase 3 study testing Progesterone in people with Preterm Birth and Twin Dichorionic Diamniotic Placenta, run by Ain Shams University at 1 site in Egypt.
Trial summary
Aim of the work The aim of this study is to assess the efficacy of the use of vaginal progesterone as a method of prevention of preterm labour in twin gestations with short cervix . Study Design: The study is designed as randomized ,placebo-controlled, clinical trial . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Twin Dichorionic Diamniotic Placenta
- What is being tested?
- Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2016to 28 Dec 2019
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- ( All pregnant women known to have Dichorionic Diamniotic twins diagnosed on 12 week dating scan will be offered transvaginal ultrasound scan to assess cervical length at 20-24 week anomaly scan ) and so inclusion criteria include:
- ( Dichorionic Diamniotic twins ) and both twins are living .
- (Short Cervix 10-25mm) Diagnosed by transvaginal ultrasound scan between 20-24 weeks .
Who cannot join
- 1 - Cervical cerclage in place or planned . 2- on tocolytic drugs . 3- medically indicated preterm delivery < 35w of gestation . 4- known allergy to progesterone or peanuts ( as the active treatment contain peanut oil) .
- 5- known contraindication to progesterone
- Liver dysfunction or disease
- Known or suspected malignancy of breast or genital organs
- Active thromboembolic disorder , or history of hormone-associated thromboembolic disorder 6- known major structural or chromosomal fetal abnormality . 7- Rupture of fetal membranes (leakage of amniotic fluid one or both sacs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Role of Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation With Short Cervix: Randomised Controlled Trial
Aim of the work The aim of this study is to assess the efficacy of the use of vaginal progesterone as a method of prevention of preterm labour in twin gestations with short cervix .
Study Design:
The study is designed as randomized ,placebo-controlled, clinical trial . All women with dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out patient clinic. Randomization of cases will be done by computer method . 156 women with dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm detected on transvaginal sonogram between 20w to 24w gestational age were enrolled in the study and were distributed in two groups:group P (cases ) and group N (controls) . The randomization allocation was 1 : 1 (vaginal progesterone capsule : placebo).
Read the detailed description
Aim of the work The aim of this study is to assess the efficacy of the use of vaginal progesterone as a method of prevention of preterm labour in twin gestations with short cervix .
Study Design:
The study is designed as randomized ,placebo-controlled, clinical trial . All women with dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out patient clinic. Randomization of cases will be done by computer method . 156 women with dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm detected on transvaginal sonogram between 20w to 24w gestational age were enrolled in the study and were distributed in two groups:group P (cases ) and group N (controls) . The randomization allocation was 1 : 1 (vaginal progesterone capsule : placebo).
Inclusion Criteria :
( All pregnant women known to have Dichorionic Diamniotic twins diagnosed on 12 week dating scan will be offered transvaginal ultrasound scan to assess cervical length at 20-24 week anomaly scan ) and so inclusion criteria include:
- ( Dichorionic Diamniotic twins ) and both twins are living .
- (Short Cervix 10-25mm) Diagnosed by transvaginal ultrasound scan between 20-24 weeks
Exclusion Criteria :
- Cervical cerclage in place or planned .
- on tocolytic drugs .
- medically indicated preterm delivery < 35w of gestation .
- known allergy to progesterone or peanuts ( as the active treatment contain peanut oil) .
- known contraindication to progesterone
- Liver dysfunction or disease
- Known or suspected malignancy of breast or genital organs
- Active thromboembolic disorder , or history of hormone-associated thromboembolic disorder
- known major structural or chromosomal fetal abnormality .
- Rupture of fetal membranes (leakage of amniotic fluid one or both sacs).
- Being tested
- Progesterone, Placebo
- Keywords
- Short cervix, twins, 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 uterocare
women will receive progesterone vaginal pesarries containing 200mg of progesterone twice daily . it will be used by the patient as one vaginal pessary per vagina twice per day .
women will be showed how to use tablets . medication will be started at 20 -24 weeks and stopped at 36+6 weeks
PlaceboOther
women will receive placebo pessary twice a day. women will be showed how to use tablets . medication will be started at 20-24 weeks and stopped at 36+6 weeks
| Study group | Role | What they receive |
|---|---|---|
| progesterone | Active comparator | 74 patients will receive progesterone pessary 200mg twice daily Receives: Drug: Progesterone |
| Placebo | Placebo comparator | 74 patients will receive placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
delivery at <37weeks of gestation
Preterm birth
Measured: 37 weeks gestation determined by 12 weeks dating scan
Secondary outcomes (3)
adverse neonatal outcome
admission/Hypoglycaemia/Respiratory distress/feeding difficulty/sepsis
Measured: From date of delivery to date of hospital discharge up to 28 days
preterm Delivery for different gestational age
preterm delivery
Measured: less than 28 weeks, 28- 32 weeks, 32-34weeks, 34-37 weeks
Maternal adverse effects
Drug adverse effects
Measured: From randomization at 20-24 weeks till 37 weeks or delivery whichever occurs sooner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study start5 Apr 2016
- Primary completion1 Sep 2018
- Study completion28 Dec 2019
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Reda, Ain Shams University
- Investigators
- Mohamed Abdelhafeez, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697331
- Sponsor's protocol ID
- AIN-2222-RCT
- Status last verified
- May 2020
- First submitted
- 27 Feb 2016
- Last updated
- 20 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation With Short Cervix: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02697331
- Acronym / sponsor ID
- AIN-2222-RCT
- Keywords
- Short cervix, twins, progesterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Apr 2016 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 3 Mar 2016 (estimated)
- 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.
Aim of the work The aim of this study is to assess the efficacy of the use of vaginal progesterone as a method of prevention of preterm labour in twin gestations with short cervix .
Study Design:
The study is designed as randomized ,placebo-controlled, clinical trial . All women with dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out patient clinic. Randomization of cases will be done by computer method . 156 women with dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm detected on transvaginal sonogram between 20w to 24w gestational age were enrolled in the study and were distributed in two groups:group P (cases ) and group N (controls) . The randomization allocation was 1 : 1 (vaginal progesterone capsule : placebo).
Detailed description
Aim of the work The aim of this study is to assess the efficacy of the use of vaginal progesterone as a method of prevention of preterm labour in twin gestations with short cervix .
Study Design:
The study is designed as randomized ,placebo-controlled, clinical trial . All women with dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out patient clinic. Randomization of cases will be done by computer method . 156 women with dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm detected on transvaginal sonogram between 20w to 24w gestational age were enrolled in the study and were distributed in two groups:group P (cases ) and group N (controls) . The randomization allocation was 1 : 1 (vaginal progesterone capsule : placebo).
Inclusion Criteria :
( All pregnant women known to have Dichorionic Diamniotic twins diagnosed on 12 week dating scan will be offered transvaginal ultrasound scan to assess cervical length at 20-24 week anomaly scan ) and so inclusion criteria include:
- ( Dichorionic Diamniotic twins ) and both twins are living .
- (Short Cervix 10-25mm) Diagnosed by transvaginal ultrasound scan between 20-24 weeks
Exclusion Criteria :
- Cervical cerclage in place or planned .
- on tocolytic drugs .
- medically indicated preterm delivery < 35w of gestation .
- known allergy to progesterone or peanuts ( as the active treatment contain peanut oil) .
- known contraindication to progesterone
- Liver dysfunction or disease
- Known or suspected malignancy of breast or genital organs
- Active thromboembolic disorder , or history of hormone-associated thromboembolic disorder
- known major structural or chromosomal fetal abnormality .
- Rupture of fetal membranes (leakage of amniotic fluid one or both sacs).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| progesterone | Active comparator | Drug: Progesterone74 patients will receive progesterone pessary 200mg twice daily |
| Placebo | Placebo comparator | Other: Placebo74 patients will receive placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ( All pregnant women known to have Dichorionic Diamniotic twins diagnosed on 12 week dating scan will be offered transvaginal ultrasound scan to assess cervical length at 20-24 week anomaly scan ) and so inclusion criteria include:
Key exclusion criteria (5 listed)
- 1 - Cervical cerclage in place or planned . 2- on tocolytic drugs . 3- medically indicated preterm delivery < 35w of gestation . 4- known allergy to progesterone or peanuts ( as the active treatment contain peanut oil) .
- 5- known contraindication to progesterone
- Liver dysfunction or disease
- Known or suspected malignancy of breast or genital organs
- Active thromboembolic disorder , or history of hormone-associated thromboembolic disorder 6- known major structural or chromosomal fetal abnormality . 7- Rupture of fetal membranes (leakage of amniotic fluid one or both sacs)
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: uterocarewomen will receive progesterone vaginal pesarries containing 200mg of progesterone twice daily . it will be used by the patient as one vaginal pessary per vagina twice per day . women will be showed how to use tablets . medication will be started at 20 -24 weeks and stopped at 36+6 weeks | Drug | progesterone |
| Placebowomen will receive placebo pessary twice a day. women will be showed how to use tablets . medication will be started at 20-24 weeks and stopped at 36+6 weeks | Other | Placebo |
Primary outcome
delivery at <37weeks of gestation
Time frame: 37 weeks gestation determined by 12 weeks dating scan
Preterm birth
3 secondary outcomes
adverse neonatal outcome
Time frame: From date of delivery to date of hospital discharge up to 28 days
preterm Delivery for different gestational age
Time frame: less than 28 weeks, 28- 32 weeks, 32-34weeks, 34-37 weeks
Maternal adverse effects
Time frame: From randomization at 20-24 weeks till 37 weeks or delivery whichever occurs sooner
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 20 May 2020.
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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.
Mohamed Abdelhafeez study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Progesterone in people with Preterm Birth and Twin Dichorionic Diamniotic Placenta, 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 5 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 20 May 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
delivery at <37weeks of gestation (time frame: 37 weeks gestation determined by 12 weeks dating scan). 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 20 May 2020.