PreeclampsiaPhase 4NCT04077853
Progesterone in Expectantly Managed Early-onset Preeclampsia
A Phase 4 study testing 17 Hydroxyprogesterone Capronate in people with Preeclampsia, run by Assiut University at 1 site in Egypt.
Trial summary
Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- 17 Hydroxyprogesterone Capronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2019to 15 Jan 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age between 20+0 and 33+6 weeks.
- Singleton pregnancy.
- Willing to participate in the study and sign the informed consent.
Who cannot join
- Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).
- Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations).
- Platelet count < 100,000/microliter (thrombocytopenia) with evidence of HELLP syndrome;
- Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values);
- Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile);
- Severe Oligohydramnios (AFI < 5cm)
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- Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;
- Eclampsia;
- Nonreassuring fetal status during daily testing (biophysical profile <4/10 and/or recurrent variable or late decelerations);
- Intrauterine fetal death.
- Patient is unable or unwilling to give consent.
- Patients currently using progesterone for other indications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of 17-Hydroxyprogesterone Caproate in Expectantly Managed Early-onset Preeclampsia: A Randomized Controlled Study
Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum
Read the detailed description
Currently there is no effective treatment for early-onset preeclampsia except for early delivery of the fetus along with the placenta. Progesterone supplementation in the form of 17-alpha-hydroxyprogesterone caproate (17-OHPC) is currently used obstetrically to prevent recurrent preterm birth in patients with pregnancies not complicated by preeclampsia. Previous studies reported that patients with severe PE had significantly lower serum progesterone concentrations than gestational age- and race-matched non-preeclamptics. Moreover, supplementation of placental ischemic rats with 17-OHPC decreased blood pressure, inflammatory cytokines, and ET-1 within 24 hours of treatment
- Conditions
- Preeclampsia
- Being tested
- 17 Hydroxyprogesterone Capronate
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17 Hydroxyprogesterone CapronateDrug
Intramuscular injection 250 mg
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | women will be given 17-OHPC 250 mg intra-muscular at admission and every 7 days thereafter in addition to other conservative measures of early-onset PE Receives: Drug: 17 Hydroxyprogesterone Capronate |
| control group | No intervention | No intervention will be given apart from the usual conservative measures of early-onset PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference between blood pressure measurements in both groups
blood pressure measured by mercury sphygmomanometer
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start15 Dec 2019
- Primary completion30 Oct 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077853
- Sponsor's protocol ID
- PPET
- Status last verified
- May 2022
- First submitted
- 1 Sep 2019
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 17-Hydroxyprogesterone Caproate in Expectantly Managed Early-onset Preeclampsia: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04077853
- Acronym / sponsor ID
- PPET
- Conditions
- Preeclampsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 4 Sep 2019 (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.
Preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum
Detailed description
Currently there is no effective treatment for early-onset preeclampsia except for early delivery of the fetus along with the placenta. Progesterone supplementation in the form of 17-alpha-hydroxyprogesterone caproate (17-OHPC) is currently used obstetrically to prevent recurrent preterm birth in patients with pregnancies not complicated by preeclampsia. Previous studies reported that patients with severe PE had significantly lower serum progesterone concentrations than gestational age- and race-matched non-preeclamptics. Moreover, supplementation of placental ischemic rats with 17-OHPC decreased blood pressure, inflammatory cytokines, and ET-1 within 24 hours of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: 17 Hydroxyprogesterone Capronatewomen will be given 17-OHPC 250 mg intra-muscular at admission and every 7 days thereafter in addition to other conservative measures of early-onset PE |
| control group | No intervention | –No intervention will be given apart from the usual conservative measures of early-onset PE |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age between 20+0 and 33+6 weeks.
- Singleton pregnancy.
- Willing to participate in the study and sign the informed consent.
Key exclusion criteria (12 listed)
- Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).
- Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations).
- Platelet count < 100,000/microliter (thrombocytopenia) with evidence of HELLP syndrome;
- Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values);
- Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile);
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 CapronateIntramuscular injection 250 mg | Drug | study group |
Primary outcome
The mean difference between blood pressure measurements in both groups
Time frame: one month
blood pressure measured by mercury sphygmomanometer
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 9 May 2022.
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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 4 study testing 17 Hydroxyprogesterone Capronate in people with Preeclampsia, run by Assiut 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 12 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 9 May 2022. 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 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?
The mean difference between blood pressure measurements in both groups (time frame: one month). 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 9 May 2022; AzTrials last refreshed its copy on 31 Oct 2026.