Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 10/5/2018 |
| Start Date: | May 2013 |
| End Date: | May 7, 2018 |
Preterm birth, defined as birth before 37 weeks' gestation, is a leading cause of infant
death and disease. Progesterone is the single most effective intervention in the prevention
of preterm birth. However, current use of this therapy is limited to certain high-risk groups
including women with a history of preterm birth and women with a short cervix. This study
seeks to evaluate the efficacy of this preventive therapy in another high-risk group: women
with arrested preterm labor. The investigators hypothesize that administration of vaginal
progesterone in women who present with preterm labor but remain undelivered 12 hours after
cessation of short-term therapy to inhibit contractions will result in lower rates of preterm
birth before 37 weeks' than will administration of placebo.
death and disease. Progesterone is the single most effective intervention in the prevention
of preterm birth. However, current use of this therapy is limited to certain high-risk groups
including women with a history of preterm birth and women with a short cervix. This study
seeks to evaluate the efficacy of this preventive therapy in another high-risk group: women
with arrested preterm labor. The investigators hypothesize that administration of vaginal
progesterone in women who present with preterm labor but remain undelivered 12 hours after
cessation of short-term therapy to inhibit contractions will result in lower rates of preterm
birth before 37 weeks' than will administration of placebo.
RESEARCH DESIGN AND METHODS
The investigators will perform a randomized, blinded, placebo-controlled trial to evaluate
the use of vaginal progesterone in women with arrested preterm labor after 24 weeks'
gestation to reduce the risk of preterm birth before 37 weeks' gestation. Women enrolled in
the study will be randomized to daily vaginal administration of progesterone (200 mg) or
placebo from time of enrollment until 36 6/7 weeks' gestation. Women will be eligible if they
have a singleton or twin gestation between 24 0/7 and 33 6/7 weeks' gestation and initially
present with regular uterine contractions and a clinical diagnosis of preterm labor but
remain undelivered without further cervical change 12 hours after discontinuation of acute
tocolytic therapy. Women may also participate if it has been less than if they are considered
eligible for discharge based on attending physician judgement prior to the 12 hour period of
time.
Randomization and Blinding- Participants in the study will be randomized using a
computer-generated randomization scheme with 1:1 allocation to receive progesterone or
placebo. Investigators and research team members, participants, and the obstetric providers
will be blinded to the allocated intervention.
Procedures-
- Data collection- Information will be recorded from the participant's medical record.
Additional study information not included in the medical record will be obtained
directly from the participant in an interview with the research team member.
- Follow-up- Regardless of whether the participant remains hospitalized or is discharged
prior to delivery, she will meet with a study coordinator every 2 weeks. During the
follow-up visit, a study team member will discuss compliance with the study drug and
possible side effects. The participant will fill out a 1-page questionnaire that asks
questions about compliance and side effects. This information will be recorded and
provided to the Data Safety and Monitoring Board at the midpoint review.
SAMPLE SIZE ESTIMATION
The investigators plan to enroll 120 patients, with a 1:1 allocation to treatment and
placebo. This sample size is adequate to detect a one-half reduction in the primary outcome,
delivery before 37 weeks.
STATISTICAL ANALYSIS
Baseline characteristics of women randomized to progesterone will be compared with women
randomized to placebo. Rates of delivery before 37 weeks' gestation will be compared among
the groups using the Chi-square test. Secondary outcomes will be evaluated using the
Chi-square test for binary outcomes and the Student t-test for continuous outcomes. Length of
time from enrollment to delivery will be analyzed using Kaplan-Meier curves and the Cox
proportional hazards model. All analyses will be performed using the intention-to-treat
principle.
The investigators will perform a randomized, blinded, placebo-controlled trial to evaluate
the use of vaginal progesterone in women with arrested preterm labor after 24 weeks'
gestation to reduce the risk of preterm birth before 37 weeks' gestation. Women enrolled in
the study will be randomized to daily vaginal administration of progesterone (200 mg) or
placebo from time of enrollment until 36 6/7 weeks' gestation. Women will be eligible if they
have a singleton or twin gestation between 24 0/7 and 33 6/7 weeks' gestation and initially
present with regular uterine contractions and a clinical diagnosis of preterm labor but
remain undelivered without further cervical change 12 hours after discontinuation of acute
tocolytic therapy. Women may also participate if it has been less than if they are considered
eligible for discharge based on attending physician judgement prior to the 12 hour period of
time.
Randomization and Blinding- Participants in the study will be randomized using a
computer-generated randomization scheme with 1:1 allocation to receive progesterone or
placebo. Investigators and research team members, participants, and the obstetric providers
will be blinded to the allocated intervention.
Procedures-
- Data collection- Information will be recorded from the participant's medical record.
Additional study information not included in the medical record will be obtained
directly from the participant in an interview with the research team member.
- Follow-up- Regardless of whether the participant remains hospitalized or is discharged
prior to delivery, she will meet with a study coordinator every 2 weeks. During the
follow-up visit, a study team member will discuss compliance with the study drug and
possible side effects. The participant will fill out a 1-page questionnaire that asks
questions about compliance and side effects. This information will be recorded and
provided to the Data Safety and Monitoring Board at the midpoint review.
SAMPLE SIZE ESTIMATION
The investigators plan to enroll 120 patients, with a 1:1 allocation to treatment and
placebo. This sample size is adequate to detect a one-half reduction in the primary outcome,
delivery before 37 weeks.
STATISTICAL ANALYSIS
Baseline characteristics of women randomized to progesterone will be compared with women
randomized to placebo. Rates of delivery before 37 weeks' gestation will be compared among
the groups using the Chi-square test. Secondary outcomes will be evaluated using the
Chi-square test for binary outcomes and the Student t-test for continuous outcomes. Length of
time from enrollment to delivery will be analyzed using Kaplan-Meier curves and the Cox
proportional hazards model. All analyses will be performed using the intention-to-treat
principle.
Inclusion Criteria:
- Singleton or twin gestation
- Estimated gestational age between 24 0/7 and 33 6/7 weeks' gestation
- Initially present with regular contractions and clinical diagnosis of preterm labor
but remain undelivered with 1) no further cervical change 12 hours after
discontinuation of acute tocolytic therapy; or 2) be considered eligible for discharge
based on attending physician judgment prior to the 12 hour period of time
- The participant's cervix must be at least 1 cm at the time of enrollment
Exclusion Criteria:
- Non-English speaking
- Rupture of membranes
- Chorioamnionitis
- Non-reassuring fetal status
- Maternal indication for delivery
- Placental abruption
- Intrauterine fetal demise
- Prenatally diagnosed major fetal anomaly
- Cervical cerclage in place
- Previous administration of progesterone during the current pregnancy for a history of
preterm birth or short cervix
- Participant is either unwilling or unable to attend follow-up study visits following
hospital discharge
We found this trial at
1
site
Saint Louis, Missouri 63110
Principal Investigator: George A Macones, MD, MSCE
Phone: 314-362-8895
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