PregnancyPhase 2PROGRESSNCT02989025
Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia
A Phase 2 study testing 17 OHPC in people with Pregnancy and Preeclampsia (PE), run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to learn if giving 17-hydroxyprogesterone caproate (17 OHPC) to mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby outcomes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, Preeclampsia (PE)
- What is being tested?
- 17 OHPC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- UMMC antepartum patients with preterm PE between 23 0/7ths and 34 0/7ths weeks gestation when initially evaluated
- Willing and able to understand study procedures and to provide informed consent
Who cannot join
- >33 weeks gestational age or <23 weeks gestation
- Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).
- Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations, minimal to absent fetal heart rate variability).
- Parameters according to current practice guidelines that exclude a patient from expectant management include the following:
- Preterm premature rupture of membranes (PPROM) > 34 weeks gestation;
- Platelet count < 100,000/microliter (thrombocytopenia) with evidence of HELLP syndrome;
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- 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)
- Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;
- Recurrent (> 2 readings > 30 minutes apart) severe hypertension despite antihypertensive therapy;
- Eclampsia;
- Pulmonary edema;
- Abruption placentae;
- Nonreassuring fetal status during daily testing (biophysical profile <4/10 and/or recurrent variable or late decelerations);
- IUFD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lorena M Amaral, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Winfred L. Wiser Hospital
Jackson, Mississippi, 39216
Babbette LaMarca, PhD, (601)815-1430, bblamarca@umc.edu
Sheila Belk, MSCI, (601)984-1690, sbelk@umc.edu
About this study
Official title: Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia-The PROGRESS Pilot Study
The purpose of this study is to learn if giving 17-hydroxyprogesterone caproate (17 OHPC) to mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby outcomes.
Read the detailed description
The OBGYN house and attending staff on duty caring for the patient will determine appropriateness for study inclusion. The treating physician will then immediately contact the MFM fellow on call and Research Division personnel to facilitate the initiation of study procedures, including the consent process and baseline blood tests. Once enrolled with informed consent, the participant will receive 17 OHPC, 250mg IM to be given at admission and every 7 days thereafter. Blood sampling of approximately 1-2 teaspoons each will be collected at baseline immediately prior to administration of 17 OHPC, then 24 hours (+-2hrs). After the first 24 hours, blood samples will be collected every 72 hrs until delivery and again 24hrs (+- 2hrs) after delivery. Placentas will be collected at delivery and the investigators will also collect information of the mother and newborn while in the hospital and until discharge including de-identified routine ultrasound.
- Conditions
- Pregnancy, Preeclampsia (PE)
- Being tested
- 17 OHPC
- 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 OHPCDrug
Also called Study Drug
The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | To determine if the addition of 17 OHPC to the management of Severe PE diagnosed prior to 34 weeks gestation improves maternal and perinatal outcomes. Receives: Drug: 17 OHPC |
| Control | No intervention | To determine how close the molecular markers are with 17 OHPC added to the management protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of maternal and perinatal outcomes
Assessment of maternal BP trends
Measured: Baseline
Secondary outcomes (1)
Change is being assessed in Maternal Outcomes
Assessment of maternal BP trends
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start22 May 2017
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Babbette Lamarca, University of Mississippi Medical Center
- Investigators
- Babbette LaMarca, PhD, Principal investigator, University of Missisippi Medical CenterSheila S Belk, Study director, UMMC Pharmacology and Toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989025
- Sponsor's protocol ID
- 2015-0029
- Acronym
- PROGRESS
- Status last verified
- Apr 2026
- First submitted
- 28 Nov 2016
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia-The PROGRESS Pilot Study
- ClinicalTrials.gov ID
- NCT02989025
- Acronym / sponsor ID
- PROGRESS / 2015-0029
- Conditions
- Pregnancy, Preeclampsia (PE)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 12 Dec 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 purpose of this study is to learn if giving 17-hydroxyprogesterone caproate (17 OHPC) to mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby outcomes.
Detailed description
The OBGYN house and attending staff on duty caring for the patient will determine appropriateness for study inclusion. The treating physician will then immediately contact the MFM fellow on call and Research Division personnel to facilitate the initiation of study procedures, including the consent process and baseline blood tests. Once enrolled with informed consent, the participant will receive 17 OHPC, 250mg IM to be given at admission and every 7 days thereafter. Blood sampling of approximately 1-2 teaspoons each will be collected at baseline immediately prior to administration of 17 OHPC, then 24 hours (+-2hrs). After the first 24 hours, blood samples will be collected every 72 hrs until delivery and again 24hrs (+- 2hrs) after delivery. Placentas will be collected at delivery and the investigators will also collect information of the mother and newborn while in the hospital and until discharge including de-identified routine ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: 17 OHPCTo determine if the addition of 17 OHPC to the management of Severe PE diagnosed prior to 34 weeks gestation improves maternal and perinatal outcomes. |
| Control | No intervention | –To determine how close the molecular markers are with 17 OHPC added to the management protocol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- UMMC antepartum patients with preterm PE between 23 0/7ths and 34 0/7ths weeks gestation when initially evaluated
- Willing and able to understand study procedures and to provide informed consent
Key exclusion criteria (16 listed)
- >33 weeks gestational age or <23 weeks gestation
- Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).
- Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations, minimal to absent fetal heart rate variability).
- Parameters according to current practice guidelines that exclude a patient from expectant management include the following:
- Preterm premature rupture of membranes (PPROM) > 34 weeks gestation;
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 OHPCAlso: Study DrugThe study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter. | Drug | Experimental |
Primary outcome
Improvement of maternal and perinatal outcomes
Time frame: Baseline
Assessment of maternal BP trends
1 secondary outcome
Change is being assessed in Maternal Outcomes
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- 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.
Lorena M Amaral, Ph.D. contact
Babbette LaMarca, PhD principal investigator
University of Missisippi Medical Center
Sheila S Belk study director
UMMC Pharmacology and Toxicology
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 OHPC in people with Pregnancy and Preeclampsia (PE), run by University of Mississippi Medical Center at 1 site in United States.
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 16 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Babbette LaMarca, PhD ((601)815-1430, bblamarca@umc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of maternal and perinatal outcomes (time frame: Baseline). 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 1 May 2026.