Preterm Premature Rupture of MembranePhase 2NCT04807543
Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes
A Phase 2 study testing 17-hydroxyprogesterone caproate and Castor Oil in people with Preterm Premature Rupture of Membrane, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the study is to assess the efficacy of 17-hydroxyprogesterone caproate (17P) therapy on the latency period in pregnant women with Preterm premature rupture of membranes. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Premature Rupture of Membrane
- What is being tested?
- 17-hydroxyprogesterone caproate and Castor Oil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2018to 10 Dec 2020
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy
- Gestational age between 24 and 34 weeks
Who cannot join
- Medical or obstetric conditions that could put them at risk for uterine atony , postpartum hemorrhage AND infection, such as
- Emergency Cesarean section.
- Chorioamnionitis.
- Placenta previa.
- Multiple gestation.
- Preeclampsia.
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- Macrosomia.
- Non reassuring fetal status or fetal distress
- Presence of fetal anomalies incompatable with life
- Woman with antepartum haemorrhage
- Diagnosis of Established preterm labor
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to assess the efficacy of 17-hydroxyprogesterone caproate (17P) therapy on the latency period in pregnant women with Preterm premature rupture of membranes.
Read the detailed description
After taking informed written consent, the recruited patients will be subjected to the following:
- Detailed history
- Personal History: Name, age ,residence ,special habits of medical importance
- Obstetric history: first day of last menstrual period for accurate estimation of gestational age and antenatal care
- Past history: history of any medical disorder or surgical history with particular emphasis on prior PPROM or preterm labor
- History of the present pregnancy: Medical or surgical condition to define high risk pregnancy.
- Examination of the patients General examination: blood pressure, pulse, temperature Abdominal examination:
- Inspection: fundal level, scars, umbilicus.
- Palpation: presence of contractions, fetal lie and presentation.
- Pelvic Examination only by sterile speculum to exclude cord prolapse , bloody liquor and cervical dilatation and effacement
- Non stress test to ensure reassuring fetal well being
- Ultrasound examination to:-
- Assess fetal viability.
- Amniotic fluid index.
- Determine gestational age.
- Exclude major anomalies.
- Placental location.
- Baseline laboratory investigations:
- Complete blood count (CBC).
- Prothrombin time (PT).
- Activated partial thromboplastin time (aPTT).
- Liver and kidney function.
The included patients were randomized using sealed opaque envelope method into one of two groups:
Group I (study group): in which 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume, intramuscular injection weekly) will be administered.
Group II (control group): in which an identical-appearing placebo (1 mL castor oil only) will be administered.
- Conditions
- Preterm Premature Rupture of Membrane
- Being tested
- 17-hydroxyprogesterone caproate, Castor Oil
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-hydroxyprogesterone caproateDrug
intramuscular injection weekly
Castor OilDrug
intramuscular injection weekly
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume)intramuscular injection Receives: Drug: 17-hydroxyprogesterone caproate |
| control group | Placebo comparator | castor oil, 1 mL total volume intramuscular injection Receives: Drug: Castor Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
prolongation of the pregnancy until a favorable gestational age
The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used
Measured: 10 to 12 weeks (up to 34.0 weeks of gestation or documentation of fetal lung maturity at 32.0 to 33.9 weeks.)
Secondary outcomes (2)
Latency .
The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used
Measured: 10 to 12 weeks (interval in weeks from randomization to delivery)
Composite neonatal morbidity
by Apgar score ,blood gases ,and labs
Measured: 1 week (from delivery to 1 week post Natal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start10 Jan 2018
- Primary completion10 Oct 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of MembraneStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807543
- Sponsor's protocol ID
- ppprom
- Status last verified
- Mar 2021
- First submitted
- 20 Feb 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT04807543
- Acronym / sponsor ID
- ppprom
- Conditions
- Preterm Premature Rupture of Membrane
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 19 Mar 2021 (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 aim of the study is to assess the efficacy of 17-hydroxyprogesterone caproate (17P) therapy on the latency period in pregnant women with Preterm premature rupture of membranes.
Detailed description
After taking informed written consent, the recruited patients will be subjected to the following:
- Detailed history
- Personal History: Name, age ,residence ,special habits of medical importance
- Obstetric history: first day of last menstrual period for accurate estimation of gestational age and antenatal care
- Past history: history of any medical disorder or surgical history with particular emphasis on prior PPROM or preterm labor
- History of the present pregnancy: Medical or surgical condition to define high risk pregnancy.
- Examination of the patients General examination: blood pressure, pulse, temperature Abdominal examination:
- Inspection: fundal level, scars, umbilicus.
- Palpation: presence of contractions, fetal lie and presentation.
- Pelvic Examination only by sterile speculum to exclude cord prolapse , bloody liquor and cervical dilatation and effacement
- Non stress test to ensure reassuring fetal well being
- Ultrasound examination to:-
- Assess fetal viability.
- Amniotic fluid index.
- Determine gestational age.
- Exclude major anomalies.
- Placental location.
- Baseline laboratory investigations:
- Complete blood count (CBC).
- Prothrombin time (PT).
- Activated partial thromboplastin time (aPTT).
- Liver and kidney function.
The included patients were randomized using sealed opaque envelope method into one of two groups:
Group I (study group): in which 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume, intramuscular injection weekly) will be administered.
Group II (control group): in which an identical-appearing placebo (1 mL castor oil only) will be administered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Drug: 17-hydroxyprogesterone caproate17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume)intramuscular injection |
| control group | Placebo comparator | Drug: Castor Oilcastor oil, 1 mL total volume intramuscular injection |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Gestational age between 24 and 34 weeks
Key exclusion criteria (11 listed)
- Medical or obstetric conditions that could put them at risk for uterine atony , postpartum hemorrhage AND infection, such as
- Non reassuring fetal status or fetal distress
- Presence of fetal anomalies incompatable with life
- Woman with antepartum haemorrhage
- Diagnosis of Established preterm labor
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-hydroxyprogesterone caproateintramuscular injection weekly | Drug | study group |
| Castor Oilintramuscular injection weekly | Drug | control group |
Primary outcome
prolongation of the pregnancy until a favorable gestational age
Time frame: 10 to 12 weeks (up to 34.0 weeks of gestation or documentation of fetal lung maturity at 32.0 to 33.9 weeks.)
The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used
2 secondary outcomes
Latency .
Time frame: 10 to 12 weeks (interval in weeks from randomization to delivery)
Composite neonatal morbidity
Time frame: 1 week (from delivery to 1 week post Natal)
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 19 Mar 2021.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-hydroxyprogesterone caproate and Castor Oil in people with Preterm Premature Rupture of Membrane, 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 2 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 19 Mar 2021. 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 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?
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?
prolongation of the pregnancy until a favorable gestational age (time frame: 10 to 12 weeks (up to 34.0 weeks of gestation or documentation of fetal lung maturity at 32.0 to 33.9 weeks.)). 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 19 Mar 2021.