Overview

This trial is active, not recruiting.

Condition pregnancy complications
Treatment progesterone
Phase phase 2/phase 3
Sponsor Stanford University
Start date October 2009
End date February 2013
Trial size 120 participants
Trial identifier NCT00946088, 11625, SU-03312009-2078

Summary

Preterm delivery is the most common cause of infant morbidity and mortality in the United States. Some women have episodes of preterm labor during their pregnancy which can be temporarily stopped. These women, however, are at high risk for delivering before term. At this time, we do not have sufficient evidence to use any medication to help prevent these women from delivering early. Recently, preliminary studies have shown that progesterone may help prevent some women at high risk for preterm delivery from delivering early. Our study will investigate whether progesterone can help this specific group of women, women with arrested preterm labor, deliver healthy infants at term.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
progesterone
Progesterone 400 mg per vagina qhs. vs polyethylene glycol 400 distearate & hydrogenated vegetable oil.
(Placebo Comparator)
progesterone
Progesterone 400 mg per vagina qhs. vs polyethylene glycol 400 distearate & hydrogenated vegetable oil.

Primary Outcomes

Measure
Reduction in delivery rate prior to 37 weeks gestation
time frame: At time of delivery

Secondary Outcomes

Measure
Birth weight, Neonatal Intensive Care Unit (NICU) admission and length of stay
time frame: At time of neonatal discharge
Neonatal morbidity and mortality
time frame: At time of neonatal discharge
Neonatal congenital abnormalities, specifically genital abnormalities
time frame: At time of neonatal discharge
Maternal chorioamnionitis, adverse medication reaction, patient report of labor symptoms and number of days of delay of delivery.
time frame: At time of maternal discharge

Eligibility Criteria

Female participants from 18 years up to 55 years old.

Inclusion Criteria:1. Pregnant women with arrested preterm labor between 24+0 to 33+6 weeks pregnant. 2. Intact membranes 3. Singleton pregnancy 4. Greater than or equal to 18 years of age 5. Cervical dilation less than or equal to 4cm Exclusion Criteria:1. Any contraindication to on-going pregnancy 2. Placental abruption 3. Placenta previa 4. Lethal fetal anomalies 5. Premature rupture of membranes 6. Multiple gestation 7. Less than 18 years old 8. Known allergy to any component of the study medication or placebo 9. Severe maternal medical illness

Additional Information

Official title Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial
Principal investigator Deirdre Judith Lyell
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Stanford University.