Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00946088
First received: July 22, 2009
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Pregnancy Complications
Drug: Progesterone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Reduction in delivery rate prior to 37 weeks gestation [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Birth weight, Neonatal Intensive Care Unit (NICU) admission and length of stay [ Time Frame: At time of neonatal discharge ] [ Designated as safety issue: No ]
  • Neonatal morbidity and mortality [ Time Frame: At time of neonatal discharge ] [ Designated as safety issue: No ]
  • Neonatal congenital abnormalities, specifically genital abnormalities [ Time Frame: At time of neonatal discharge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Progesterone Drug: Progesterone
Progesterone 400 mg per vagina qhs. vs polyethylene glycol 400 distearate & hydrogenated vegetable oil.
Placebo Comparator: Polyethylene glycol & hydrogenated vegetable oil Drug: Progesterone
Progesterone 400 mg per vagina qhs. vs polyethylene glycol 400 distearate & hydrogenated vegetable oil.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946088

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 Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00946088     History of Changes
Other Study ID Numbers: SU-03312009-2078, 11625
Study First Received: July 22, 2009
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014