Vaginal Progesterone as a Treatment for Women Active Preterm Labor

Condition(s) targeted: Labor, Premature

Intervention: Vaginal progesterone gel (Drug); Placebo vaginal gel (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
Tulin Ozcan, MD, Principal Investigator, Affiliation: University of Rochester

Overall contact:
Tulin Ozcan, MD, Phone: 585-275-7480, Email: tulin_ozcan@urmc.rochester.edu

The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery, cervical length and biomarkers of preterm delivery in women diagnosed with and treated with medication to stop preterm labor.

Official title: Vaginal Progesterone in Patients With Active Preterm Labor

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Latency to delivery

Secondary outcome:

Cervical length

Delivery prior to 37, 34 and 32 weeks

Number of subsequent hospital admissions for preterm labor

Detailed description: Preterm birth remains a leading cause of perinatal mortality and morbidity. Despite advances in obstetric and pediatric care, the incidence of preterm birth has increased by more than 20% in the last two decades. Approximately 12. 8% of births are preterm, however these account for more than 75% of all perinatal morbidity and mortality. Currently prophylactic progesterone administration is the most effective method available for the prevention of recurrent preterm birth. Prior studies have examined the impact of progesterone in women with recurrent preterm birth and cervical shortening. The possible use of progesterone in women experiencing active preterm labor may address the highest risk condition, however, there have not been any clinical trials to date examining this use of vaginal progesterone. Inflammation and decidual hemorrhage are among the proposed mechanisms that appear to be related to preterm labor. We will use a double blinded randomized drug placebo design to study the proposed outcomes in women diagnosed with preterm labor and planned to have standard of care tocolytic therapy. Women will be randomized to daily vaginal progesterone gel or placebo and will be maintained on the drug or placebo until delivery or 36 6/7 weeks.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Age 18 or older

- Singleton gestation

- Gestational age between 24 0/7 and 33 6/7 weeks of pregnancy by best obstetric

estimate

- Preterm labor, defined as more than 6 uterine contractions in 30 minutes associated

with cervical change, either shortening and/or dilation by manual exam.

- Management with standard of care tocolytic therapy (nifedipine)

- Planned delivery at Strong Memorial Hospital or Highland Hospital

Exclusion Criteria:

- Cervical dilation more than 4 cm.

- Evidence of rupture of membranes

- Negative fetal fibronectin (if done prior to admission)

- Cervical length greater than 3 cm

- Presence of cervical cerclage

- Major fetal anomaly

- Small for gestational age, i. e., fetuses with estimated fetal weight below the 10th

percentile by ultrasound

- Evidence of chorioamnionitis (Temperature >100. 4oF with uterine tenderness and

maternal or fetal tachycardia or purulent discharge)

- Suspected placental abruption or significant hemorrhage

- Category III fetal heart rate pattern

- Presence of co-existing medical conditions, including maternal diabetes and

hypertension and seizure disorder

- Use of any progesterone in current pregnancy within 4 weeks of enrollment

- First dose of standard tocolytic therapy more than 6 hours prior to randomization

- Allergies to progesterone and progesterone gel

Tulin Ozcan, MD, Phone: 585-275-7480, Email: tulin_ozcan@urmc.rochester.edu

Strong Memorial Hospital, Rochester, New York 14642, United States; Recruiting
TULIN OZCAN, MD, Phone: 585-275-7480, Email: tulin_ozcan@urmc.rochester.edu
Tulin Ozcan, MD, Principal Investigator
David Hackney, MD, MS, Sub-Investigator
Danielle Durie, MD, Sub-Investigator

Starting date: July 2010
Last updated: September 21, 2010