Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00946088
Recruitment Status : Terminated (lower than expected enrollment)
First Posted : July 24, 2009
Results First Posted : February 8, 2017
Last Update Posted : March 16, 2017
Information provided by (Responsible Party):
Deirdre Judith Lyell, Stanford University

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 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

Resource links provided by the National Library of Medicine

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.

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

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00946088

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Deirdre Judith Lyell, MD Stanford University

Responsible Party: Deirdre Judith Lyell, Associate Professor, Stanford University Identifier: NCT00946088     History of Changes
Other Study ID Numbers: SU-03312009-2078
11625 ( Other Identifier: Stanford University Med. Center IRB )
First Posted: July 24, 2009    Key Record Dates
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
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs