Preterm LaborPhase 2NCT03537287
Different Types of Progesterone in the Prevention of Preterm Labor
A Phase 2 study testing 17 alpha hydroxyprogestrone caproate, Vaginal progesterone and Oral dydrogesterone in people with Preterm Labor, run by Ain Shams University at 1 site in Egypt.
Trial summary
Preterm birth is a common problem in obstetric care,with estimates ranging from 5% in several European countries to 18% in some African countries, Preterm labor defined as delivery before 37 completed weeks is the leading cause of perinatal and neonatal morbidity and mortality and strongly related to the developmental… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- 17 alpha hydroxyprogestrone caproate, Vaginal progesterone and Oral dydrogesterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to Aug 2018
- Phase
- Phase 2
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Living fetus with gestational age 16-18weeks (calculated according to date of last menstrual period confirmed with earlier ultrasound examination).
- Presence of risk factor for preterm labor:
- Previous spontaneous preterm labor in previous singleton Pregnancy, OR
- Previous spontaneous second trimestric miscarriage less than 3 times, OR
- Short cervix less than 25mm diagnosed during midtrimesteric transvaginal ultrasound examination at 16-18 weeks with or without history of previous preterm labor.
Who cannot join
- Multiple pregnancy.
- Medical or obstetric conditions requiring termination of pregnancy
- Contraindication to progesterone administration or its use earlier in this pregnancy
- Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy.
- Liver dysfunction or disease.
- Known or suspected malignancy of breast or genital organs.
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- Undiagnosed vaginal bleeding.
- Missed abortion.
- Known sensitivity to progesterone injection.
- Known sensitivity to sesame oil/seeds.
- Congenital fetal anomalies
- Cervical cerclage in the current pregnancy.
- Presence of uterine anomalies (Unicornuate uterus , Uterus didelphys, bicornuate uterus,Septated uterus) or uterine fibroid.
- Presence of history of chronic hypertetion, chronic liver or kidney diseases, and pregnancy induced hypertension.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain SHams Maternity Hospital
Cairo, Abbaseya
Mohamed Samy, MD
About this study
Official title: Intramuscular 17Alpha-hydroxyprogestrone, Progesterone Suppositories and Dydrogesterone Tablets in Preventing Preterm Labor
Preterm birth is a common problem in obstetric care,with estimates ranging from 5% in several European countries to 18% in some African countries, Preterm labor defined as delivery before 37 completed weeks is the leading cause of perinatal and neonatal morbidity and mortality and strongly related to the developmental and neurological disabilities later in life..
There is still considerable uncertainty regarding the optimal progesterone type, route of administration, dosage and timing of start of therapy to prevent preterm labor in risky women
Read the detailed description
This study aims to compare between the efficacy of intramuscular 17alpha-hydroxyprogestrone, progesterone vaginal suppositories and dydrogesterone oral tablets in prevention of preterm labor in high risk women.
All women will be counseled regarding mode of intervention and informed consent will be obtained. All cases will be subjected to complete history taking, routine antenatal examination and investigations, treatment of genital or urinary tract infections if diagnosed. Routine obstetric ultrasound examination and measurement of cervical length by transvaginal ultrasound will be carried out at 16-18weeks of pregnancy.
The study population will be randomly distributed according to the mode of intervention into 3 groups.
Randomization is performed using a Computer-generated randomization system. Blinding of the intervention is not feasible in this trial (owing to the different route of administration of the studied drugs).Table of randomization is obtained
Group 1:
Women who will take intramuscular 17 alpha hydroxyprogestrone caproate
Dose:
250 mg intramuscularly, once weekly starting from 16 weeks till delivery or 36 weeks.
Group 2 :
Women who will take progesterone 200mg vaginal suppositories.
Dose:
Once per day starting from 16 weeks till delivery or 36 weeks
Group 3 :
Women who will take oral dydrogesterone
Dose:
Take 2 tablets a day starting from 16 weeks till delivery or 36 weeks
Color Doppler blood flow velocity examination of fetal circulation will be performed by an independent investigator blinded to treatment before treatment \&after two weeks of treatment.
- Conditions
- Preterm Labor
- Being tested
- 17 alpha hydroxyprogestrone caproate, Vaginal progesterone, Oral dydrogesterone
- 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.
17 alpha hydroxyprogestrone caproateDrug
250 mg of 17 alpha hydroxyprogestrone caproate weekly
Vaginal progesteroneDrug
200 mg of vaginal progesterone daily
Oral dydrogesteroneDrug
2 tablets of dydrogesterone daily
| Study group | Role | What they receive |
|---|---|---|
| 17 alpha hydroxyprogestrone caproate Group | Active comparator | Patients will receive 250 mg of 17 alpha hydroxyprogestrone caproate intramuscularly once weekly starting from 16 weeks till delivery or 36 weeks. Receives: Drug: 17 alpha hydroxyprogestrone caproate |
| Vaginal progesterone Group | Active comparator | Patients will receive vaginal progesterone 200 mg once per day starting from 16 weeks till delivery or 36 weeks. Receives: Drug: Vaginal progesterone |
| Oral dydrogesterone Group | Active comparator | Patients will receive 2 tablets of oral dydrogesterone daily starting from 16 weeks till delivery or 36 weeks Receives: Drug: Oral dydrogesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age in weeks at delivery.
using either the last menstrual period in patients with regular cycles or early first trimester ultrasound to calculate the gestational age in weeks at delivery
Measured: 6 months
Secondary outcomes (7)
Hemodynamic changes in fetoplacental circulation
Measurement of U/S Doppler indices of umbilical artery and middle cerebral artery (namely PI, RI and S/D ratio) in fetal circulation
Measured: 6 months
Unsatisfactory response
Number of patients who needed to increase the dose above the recommended initial dose.
Measured: 6 months
Failure of prevention of preterm labor
Number of patients who suffered preterm labor and needed tocolysis
Measured: 6 months
Birth weight
Birth weight in Kg
Measured: 6 months
Neonatal APGAR score
Neonatal Apgar score at 1 and 5 min.
Measured: 6 months
Need for NICU admission
Number of patients whose neonates were admitted to NICU
Neonatal mortality.
Measured: 6 months
Neonatal mortality
Number of neonatal deaths
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study startJul 2016
- Primary completionJul 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed mahmoud samy, Ain Shams University
- Investigators
- Mohamed Samy, MD, Principal investigator, M Samy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537287
- Sponsor's protocol ID
- PDPTL
- Status last verified
- May 2018
- First submitted
- 25 Apr 2016
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular 17Alpha-hydroxyprogestrone, Progesterone Suppositories and Dydrogesterone Tablets in Preventing Preterm Labor
- ClinicalTrials.gov ID
- NCT03537287
- Acronym / sponsor ID
- PDPTL
- Conditions
- Preterm Labor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 25 May 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.
Preterm birth is a common problem in obstetric care,with estimates ranging from 5% in several European countries to 18% in some African countries, Preterm labor defined as delivery before 37 completed weeks is the leading cause of perinatal and neonatal morbidity and mortality and strongly related to the developmental and neurological disabilities later in life..
There is still considerable uncertainty regarding the optimal progesterone type, route of administration, dosage and timing of start of therapy to prevent preterm labor in risky women
Detailed description
This study aims to compare between the efficacy of intramuscular 17alpha-hydroxyprogestrone, progesterone vaginal suppositories and dydrogesterone oral tablets in prevention of preterm labor in high risk women.
All women will be counseled regarding mode of intervention and informed consent will be obtained. All cases will be subjected to complete history taking, routine antenatal examination and investigations, treatment of genital or urinary tract infections if diagnosed. Routine obstetric ultrasound examination and measurement of cervical length by transvaginal ultrasound will be carried out at 16-18weeks of pregnancy.
The study population will be randomly distributed according to the mode of intervention into 3 groups.
Randomization is performed using a Computer-generated randomization system. Blinding of the intervention is not feasible in this trial (owing to the different route of administration of the studied drugs).Table of randomization is obtained
Group 1:
Women who will take intramuscular 17 alpha hydroxyprogestrone caproate
Dose:
250 mg intramuscularly, once weekly starting from 16 weeks till delivery or 36 weeks.
Group 2 :
Women who will take progesterone 200mg vaginal suppositories.
Dose:
Once per day starting from 16 weeks till delivery or 36 weeks
Group 3 :
Women who will take oral dydrogesterone
Dose:
Take 2 tablets a day starting from 16 weeks till delivery or 36 weeks
Color Doppler blood flow velocity examination of fetal circulation will be performed by an independent investigator blinded to treatment before treatment \&after two weeks of treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 17 alpha hydroxyprogestrone caproate Group | Active comparator | Drug: 17 alpha hydroxyprogestrone caproatePatients will receive 250 mg of 17 alpha hydroxyprogestrone caproate intramuscularly once weekly starting from 16 weeks till delivery or 36 weeks. |
| Vaginal progesterone Group | Active comparator | Drug: Vaginal progesteronePatients will receive vaginal progesterone 200 mg once per day starting from 16 weeks till delivery or 36 weeks. |
| Oral dydrogesterone Group | Active comparator | Drug: Oral dydrogesteronePatients will receive 2 tablets of oral dydrogesterone daily starting from 16 weeks till delivery or 36 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Singleton pregnancy
- Living fetus with gestational age 16-18weeks (calculated according to date of last menstrual period confirmed with earlier ultrasound examination).
- Presence of risk factor for preterm labor:
Key exclusion criteria (14 listed)
- Multiple pregnancy.
- Medical or obstetric conditions requiring termination of pregnancy
- Contraindication to progesterone administration or its use earlier in this pregnancy
- Congenital fetal anomalies
- Cervical cerclage 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 |
|---|---|---|
| 17 alpha hydroxyprogestrone caproate250 mg of 17 alpha hydroxyprogestrone caproate weekly | Drug | 17 alpha hydroxyprogestrone caproate Group |
| Vaginal progesterone200 mg of vaginal progesterone daily | Drug | Vaginal progesterone Group |
| Oral dydrogesterone2 tablets of dydrogesterone daily | Drug | Oral dydrogesterone Group |
Primary outcome
Gestational age in weeks at delivery.
Time frame: 6 months
using either the last menstrual period in patients with regular cycles or early first trimester ultrasound to calculate the gestational age in weeks at delivery
7 secondary outcomes
Hemodynamic changes in fetoplacental circulation
Time frame: 6 months
Unsatisfactory response
Time frame: 6 months
Failure of prevention of preterm labor
Time frame: 6 months
Birth weight
Time frame: 6 months
Neonatal APGAR score
Time frame: 6 months
Need for NICU admission
Time frame: 6 months
Neonatal mortality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Individual participant dataSharing planned: No
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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 Samy, MD principal investigator
M Samy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 17 alpha hydroxyprogestrone caproate, Vaginal progesterone and Oral dydrogesterone in people with Preterm Labor, 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 6 inclusion and 14 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 29 May 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mohamed Samy, MD (01001947488, mohammedsamy8132@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age in weeks at delivery. (time frame: 6 months). 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 29 May 2018.