Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia

ConditionsPregnancy Preeclampsia (PE)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorUniversity of Mississippi Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

>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).

Preterm premature rupture of membranes (PPROM) > 34 weeks gestation;

Trial design

Design model

Single group

Treatments tested in this trial

17 OHPC
Drug
The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: ExperimentalExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Improvement of maternal and perinatal outcomes

Assessment of maternal BP trends

Time frame

Baseline

Secondary outcomes

Change is being assessed in Maternal Outcomes

Assessment of maternal BP trends

Time frame

24 hours

Other outcomes

Change is being assessed in Maternal Outcomes

Assessment of maternal BP trends

Time frame

48 hours

Change is being assessed in Maternal Outcomes

Assessment of maternal BP trends

Time frame

Until delivery

Assessment of Placental Abruption

Time frame

Baseline until delivery

Assessment of Pulmonary edema

Time frame

Change from Baseline until delivery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Mississippi Medical Center

Lead sponsor

Source ClinicalTrials.gov

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