Premature LabourPhase 4NCT02338830
Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix
A Phase 4 study testing Progesterone in people with Premature Labour, run by Mohamed Sayed Abdelhafez at 2 sites in Egypt.
Trial summary
To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Premature Labour
- What is being tested?
- Progesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesEgypt
- Study dates
- Jun 2012to Nov 2014
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women pregnant in dichorionic twins.
- Transvaginal sonographic cervical length is 20-25 mm at 20-24 weeks gestational age.
- No symptoms, signs or other risk factors for preterm labor.
Who cannot join
- Age < 20 years or > 35 years.
- Known allergy or contraindication (relative or absolute) to progesterone therapy.
- Pregnancy by in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI).
- Monochorionic twins.
- Known major fetal structural or chromosomal abnormality.
- Intrauterine death of one fetus or death of both fetuses.
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- Fetal reduction in current pregnancy.
- Cervical cerclage in current pregnancy.
- Medical conditions that may lead to preterm delivery.
- Rupture of membranes.
- Vaginal bleeding.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
Private practice settings
Al Mansurah, Dakahlia Governorate
About this study
To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix
Read the detailed description
Women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24 weeks gestational age without symptoms, signs or other risk factors of preterm labor will be included in the study. All women will be randomly divided into two groups; one group (study group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 20-24 weeks gestational age (study group) and the other group received no treatment (control group)
- Conditions
- Premature Labour
- Being tested
- Progesterone
- Keywords
- Twins, Preterm labor, Progesterone, Short cervix
- 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
Also called Cyclogest
Women received vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) in a dose of 400 mg daily beginning at 20-24 weeks gestational age
| Study group | Role | What they receive |
|---|---|---|
| Progesterone group | Active comparator | Women received vaginal progesterone suppositories Receives: Drug: Progesterone |
| No treatment group | No intervention | Women received no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm labor before 34 weeks
Measured: Up to 34 weeks gestational age
Secondary outcomes (2)
Neonatal respiratory distress syndrome (RDS)
Measured: At birth
Early neonatal death (END).
Measured: One month after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJun 2012
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature LabourStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Sayed Abdelhafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Sayed Abdelhafez, Mansoura University
- Investigators
- Waleed El-refaie, Dr, Principal investigator, Mansoura UniversityMohamed S Abdelhafez, Dr, Study director, Mansoura UniversityAhmed M Badawy, Prof, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338830
- Sponsor's protocol ID
- WR1
- Status last verified
- Jan 2015
- First submitted
- 24 Dec 2014
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix
- ClinicalTrials.gov ID
- NCT02338830
- Acronym / sponsor ID
- WR1
- Conditions
- Premature Labour
- Keywords
- Twins, Preterm labor, Progesterone, Short cervix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Mohamed Sayed AbdelhafezUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Jan 2015 (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.
To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix
Detailed description
Women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24 weeks gestational age without symptoms, signs or other risk factors of preterm labor will be included in the study. All women will be randomly divided into two groups; one group (study group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 20-24 weeks gestational age (study group) and the other group received no treatment (control group)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone group | Active comparator | Drug: ProgesteroneWomen received vaginal progesterone suppositories |
| No treatment group | No intervention | –Women received no treatment |
Who may qualify
- Ages
- 20 to 35 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 20-25 mm at 20-24 weeks gestational age.
- No symptoms, signs or other risk factors for preterm labor.
Key exclusion criteria (11 listed)
- Age < 20 years or > 35 years.
- Known allergy or contraindication (relative or absolute) to progesterone therapy.
- Pregnancy by in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI).
- Monochorionic twins.
- Known major fetal structural or chromosomal abnormality.
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: CyclogestWomen received vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) in a dose of 400 mg daily beginning at 20-24 weeks gestational age | Drug | Progesterone group |
Primary outcome
Preterm labor before 34 weeks
Time frame: Up to 34 weeks gestational age
2 secondary outcomes
Neonatal respiratory distress syndrome (RDS)
Time frame: At birth
Early neonatal death (END).
Time frame: One month after birth
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 15 Jan 2015.
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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.
Waleed El-refaie, Dr principal investigator
Mansoura University
Mohamed S Abdelhafez, Dr study director
Mansoura University
Ahmed M Badawy, Prof study chair
Mansoura University
2 sites 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 Premature Labour, run by Mohamed Sayed Abdelhafez at 2 sites 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 11 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 15 Jan 2015. 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 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 before 34 weeks (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 Jan 2015.