Premature LabourPhase 4NCT02673359
Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM
A Phase 4 study testing Progesterone and Cervical cerclage in people with Premature Labour, run by Mohamed Sayed Abdelhafez at 3 sites in Egypt.
Trial summary
The aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor. 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 and Cervical cerclage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesEgypt
- Study dates
- Feb 2016to Jan 2024
- 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 with singleton pregnancy.
- History of preterm labor and/or midtrimester miscarriage in a previous pregnancy.
- Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation.
Who cannot join
- Age < 20 or > 35 years.
- Congenital uterine malformation.
- Multifetal pregnancy.
- Known major fetal structural or chromosomal abnormality.
- Known allergy or contraindication (relative or absolute) to progesterone therapy.
- Presence of contraindication to cervical cerclage.
- Medical conditions complicating pregnancy.
- Vaginal bleeding.
Trial locations and contacts
3 sites in 1 country.
Waleed El-refaie, Dr contact
Egypt3 sites, 3 recruiting
- Recruiting
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
- Recruiting
Private practice settings
Al Mansurah, Dakahlia Governorate
- Recruiting
Obstetrics and Gynecology Department in Port Said University
Port Said
About this study
Official title: Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Sonographic Short Cervix and History of Preterm Labor and/or Midtrimester Miscarriage
The aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor.
Read the detailed description
Women with singleton pregnancy and history of preterm labor and/or midtrimester miscarriage in a previous pregnancy will be selected for serial assessment of the cervical length by transvaginal sonography (TVS) starting from 16 weeks till 24 weeks of gestation. Eligible participants in our study will be those who have cervical length of 15-25 mm at 16-24 weeks of gestation. At 16-24 weeks gestational age, all women participating in the study will be randomly allocated into two groups; progesterone group and cerclage group. For women in the progesterone group, vaginal progesterone suppositories will be given in a dose of 400 mg/day. For women in the cerclage group, McDonald cervical cerclage will be performed.
- Conditions
- Premature Labour
- Being tested
- Progesterone, Cervical cerclage
- Keywords
- Preterm labor, Short cervix, Progesterone, Cervical cerclage
- 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, Prontogest
Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day
Cervical cerclageProcedure or surgery
Also called Cervical stitch
Cervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage)
| Study group | Role | What they receive |
|---|---|---|
| Progesterone group | Active comparator | Vaginal progesterone suppositories will be given Receives: Drug: Progesterone |
| Cerclage group | Active comparator | Cervical cerclage will be performed. Receives: Procedure: Cervical cerclage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm labor before 35 weeks
Measured: Up to 35 weeks gestational age
Secondary outcomes (4)
Delivery before 37 weeks
Measured: Up to 37 weeks gestational age
Low birth weight (LBW)
Birth weight of a living neonate of < 2500 gm regardless of gestational age
Measured: At birth
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 posted3 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
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, Port Said UniversityMohamed S Abdelhafez, Dr, Study director, Mansoura UniversityAhmed M Badawy, Prof, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673359
- Sponsor's protocol ID
- WR2
- Status last verified
- Apr 2023
- First submitted
- 1 Feb 2016
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Sonographic Short Cervix and History of Preterm Labor and/or Midtrimester Miscarriage
- ClinicalTrials.gov ID
- NCT02673359
- Acronym / sponsor ID
- WR2
- Conditions
- Premature Labour
- Keywords
- Preterm labor, Short cervix, Progesterone, Cervical cerclage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Mohamed Sayed AbdelhafezUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 3 Feb 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.
The aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor.
Detailed description
Women with singleton pregnancy and history of preterm labor and/or midtrimester miscarriage in a previous pregnancy will be selected for serial assessment of the cervical length by transvaginal sonography (TVS) starting from 16 weeks till 24 weeks of gestation. Eligible participants in our study will be those who have cervical length of 15-25 mm at 16-24 weeks of gestation. At 16-24 weeks gestational age, all women participating in the study will be randomly allocated into two groups; progesterone group and cerclage group. For women in the progesterone group, vaginal progesterone suppositories will be given in a dose of 400 mg/day. For women in the cerclage group, McDonald cervical cerclage will be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone group | Active comparator | Drug: ProgesteroneVaginal progesterone suppositories will be given |
| Cerclage group | Active comparator | Procedure: Cervical cerclageCervical cerclage will be performed. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with singleton pregnancy.
- History of preterm labor and/or midtrimester miscarriage in a previous pregnancy.
- Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation.
Key exclusion criteria (8 listed)
- Age < 20 or > 35 years.
- Congenital uterine malformation.
- Multifetal pregnancy.
- Known major fetal structural or chromosomal abnormality.
- Known allergy or contraindication (relative or absolute) to progesterone therapy.
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: Cyclogest, ProntogestVaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day | Drug | Progesterone group |
| Cervical cerclageAlso: Cervical stitchCervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage) | Procedure or surgery | Cerclage group |
Primary outcome
Preterm labor before 35 weeks
Time frame: Up to 35 weeks gestational age
4 secondary outcomes
Delivery before 37 weeks
Time frame: Up to 37 weeks gestational age
Low birth weight (LBW)
Time frame: At birth
Neonatal respiratory distress syndrome (RDS)
Time frame: At birth
Early neonatal death (END)
Time frame: One month after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Premature Labour
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Maternal Stress on Human Milk and Infant Outcomes
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Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
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IL-6 and Lactates in Cord Blood and Neonatal Outcomes
Fetal Infection, Fetal Inflammatory Response Syndrome
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 contact
Waleed El-refaie, Dr principal investigator
Port Said University
Mohamed S Abdelhafez, Dr study director
Mansoura University
Ahmed M Badawy, Prof study chair
Mansoura University
3 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 and Cervical cerclage in people with Premature Labour, run by Mohamed Sayed Abdelhafez at 3 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 8 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 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed El-refaie, Dr (wrefaie@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm labor before 35 weeks (time frame: Up to 35 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 10 Apr 2023.