RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

657 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of early delivery and improves the health of their baby.

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Detailed Description

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Preterm births, defined as the delivery of a baby less than 37 weeks of gestation, are responsible for the majority of neonatal mortality and morbidities. Studies have shown that a number of risk factors, including never having a baby before and having a short cervix are associated with early delivery. Recently the NICHD did a study in women who were pregnant again after having delivered preterm. It showed that giving 17 alpha-hydroxyprogesterone caproate (17P) medication during pregnancy decreased the chance of delivering another preterm baby by 34%. This placebo-controlled randomized clinical trial will address the primary research question: does treatment with 17P initiated before 23 weeks of gestation prevent delivery prior to 37 weeks in nulliparous women with a singleton gestation who have a short cervix?

Conditions

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Preterm Delivery Cervical Length

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Treatment with 17 alpha-hydroxyprogesterone caproate via weekly injections of 250 mg of 17p until 37 weeks gestation or delivery vs. weekly injections of placebo oil until 37 weeks gestation or delivery.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Patients and care providers are masked to treatment assignment.

Study Groups

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17 alpha-hydroxyprogesterone caproate

250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery

Group Type ACTIVE_COMPARATOR

17 alpha-hydroxyprogesterone caproate

Intervention Type DRUG

Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.

Placebo

Placebo oil given by weekly injection until 37 weeks gestation or delivery.

Group Type PLACEBO_COMPARATOR

Placebo Oil

Intervention Type OTHER

Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative

Interventions

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17 alpha-hydroxyprogesterone caproate

Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.

Intervention Type DRUG

Placebo Oil

Placebo oil is a 250 mg/mL solution of castor oil with benzyl benzoate and benzyl alcohol as a preservative

Intervention Type OTHER

Other Intervention Names

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17 AHP

Eligibility Criteria

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Inclusion Criteria

* Nulliparous
* Cervical length as measured on transvaginal examination \< 30mm between gestational ages of 16 weeks 0 days to 22 weeks 3 days
* Gestational age 16 weeks 3 days to 22 weeks 6 days at time of randomization

Exclusion Criteria

* Multifetal gestation
* Progesterone treatment after 14 weeks 6 days during current pregnancy
* Vaginal bleeding, heavier than spotting, after 15 weeks 6 days
* Amniotic membranes prolapsed beyond external os
* Preterm rupture of membranes
* Fetal anomaly
* Pregnancy without a viable fetus
* Current or planned cervical cerclage
* Congenital Mullerian abnormality of the uterus
* Contraindication to intra-muscular injections
* Hypertension requiring medication
* Diabetes managed with insulin or oral hypoglycemic agents
* DES exposure
* Cervical surgery such as cold knife conization
* Planned indicated preterm delivery
* Participation in another interventional study that influences age at delivery
* Participation in this trial in a previous pregnancy
* Prenatal care or delivery planned outside a MFMU Network center

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes