Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial
|Pregnancy Complications||Drug: Progesterone Drug: Polyethylene glycol&hydrogenated vegetable oil.||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial|
- Reduction in Delivery Rate Prior to 37 Weeks Gestation [ Time Frame: Up to 37 weeks of gestation ]Reduction in delivery rate prior to 37 weeks gestation (preterm birth).
- Maternal Chorioamnionitis [ Time Frame: Up to maternal hospital discharge ]
- Maternal Anticipated Adverse Medication Reaction [ Time Frame: Up to the maternal discharge from delivery hospitalization ]
- Birthweight [ Time Frame: At the time of newborn birth ]Newborn birthweight in grams
- Neonatal Intensive Care Unit (NICU) Admission [ Time Frame: At time of neonatal discharge ]
- Neonatal Morbidity [ Time Frame: Up to 28 days after neonatal birth ]
- Neonatal Mortality [ Time Frame: Up to 28 days after neonatal birth ]
- Neonatal Congenital Abnormalities [ Time Frame: Up to the time of neonatal discharge from the delivery hospital ]
- Number of Days Delay of Delivery [ Time Frame: Up to the time of delivery ]Number of days from intervention to delivery
|Study Start Date:||October 2009|
|Study Completion Date:||March 2015|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Progesterone
Progesterone 400mg per vagina qhs.
Progesterone 400 mg per vagina qhs.
Placebo Comparator: Polyethylene glycol&hydrogenated vegetable oil
Polyethylene glycol&hydrogenated vegetable oil per vagina
Drug: Polyethylene glycol&hydrogenated vegetable oil.
Placebo Comparator: Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina qhs.
The purpose of this study is to test the efficacy of progesterone in prolonging human pregnancies complicated by arrested preterm labor. Animal labor has not been shown to be equivalent to human labor and would not be an appropriate substitute for this study.
In addition, this medication has been previously used in pregnant women without any evidence of significant harm to the mother or fetus. Women will be approached for enrollment in the study during their hospitalization for preterm labor. If they choose to enroll, they will have weekly MD visits at the obstetrical clinic, daily use of vaginal progesterone that will be self administered, and routine obstetric care at the time of recurrent labor and delivery. The daily progesterone is not a part of routine care for these patients. In addition, we will ask patients to fill out a written questionaire one week after starting the medication to describe any subjective symptoms that may be associated with this medication. Finally, we will assess the peripheral levels of progesterone with a blood draw prior to starting the mediation, one week after starting the medication, and at the time of recurrent pre-term labor or delivery. The first two of these blood draws will be in addition to the standard treatment. The final blood draw will involve collecting an extra sample at a time when the participant would normally have blood drawn as a part of routine care.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946088
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Deirdre Judith Lyell, MD||Stanford University|