Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial

• ClinicalTrials.gov Identifier: NCT00946088
• Recruitment Status: Terminated
• First Posted: July 24, 2009
• Results First Posted: February 8, 2017
• Last Update Posted: March 16, 2017
• Sponsor: Stanford University
• Information provided by (Responsible Party): Deirdre Judith Lyell, Stanford University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pregnancy Complications	Drug: Progesterone; Drug: Polyethylene glycol&hydrogenated vegetable oil.	Phase 2; Phase 3

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• 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
• Study Start Date: October 2009
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: March 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Progesterone; Progesterone 400mg per vagina qhs.	Drug: Progesterone; 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.

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. Maternal Chorioamnionitis [ Time Frame: Up to maternal hospital discharge ]
2. Maternal Anticipated Adverse Medication Reaction [ Time Frame: Up to the maternal discharge from delivery hospitalization ]
3. Birthweight [ Time Frame: At the time of newborn birth ]
   Newborn birthweight in grams
4. Neonatal Intensive Care Unit (NICU) Admission [ Time Frame: At time of neonatal discharge ]
5. Neonatal Morbidity [ Time Frame: Up to 28 days after neonatal birth ]
6. Neonatal Mortality [ Time Frame: Up to 28 days after neonatal birth ]
7. Neonatal Congenital Abnormalities [ Time Frame: Up to the time of neonatal discharge from the delivery hospital ]
8. Number of Days Delay of Delivery [ Time Frame: Up to the time of delivery ]
   Number of days from intervention to delivery

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Deirdre Judith Lyell, MD; Stanford University

More Information

• Responsible Party: Deirdre Judith Lyell, Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT00946088
• Other Study ID Numbers: SU-03312009-2078; 11625 ( Other Identifier: Stanford University Med. Center IRB )
• First Posted: July 24, 2009
• Results First Posted: February 8, 2017
• Last Update Posted: March 16, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Pregnancy Complications; Progesterone; Progestins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs