Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Pregnancy Complications
• Intervention / Treatment: Drug: Progesterone; Drug: Polyethylene glycol&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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Delivery Rate Prior to 37 Weeks Gestation	Reduction in delivery rate prior to 37 weeks gestation (preterm birth).	Up to 37 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Chorioamnionitis		Up to maternal hospital discharge
Maternal Anticipated Adverse Medication Reaction		Up to the maternal discharge from delivery hospitalization
Birthweight	Newborn birthweight in grams	At the time of newborn birth
Neonatal Intensive Care Unit (NICU) Admission		At time of neonatal discharge
Neonatal Morbidity		Up to 28 days after neonatal birth
Neonatal Mortality		Up to 28 days after neonatal birth
Neonatal Congenital Abnormalities		Up to the time of neonatal discharge from the delivery hospital
Number of Days Delay of Delivery	Number of days from intervention to delivery	Up to the time of delivery

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Deirdre Judith Lyell, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Actual): March 16, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: SU-03312009-2078; 11625 (Stanford University Med. Center IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No