Oral Progesterone for Prevention of Preterm Birth

Fetal Medicine Foundation (FMF)

Status and phase: Completed; Phase 3

Conditions: Preterm Birth

Treatments: Drug: Identical Placebo tablet; Drug: oral micronized progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT01180296

MVH-MP-Pilot-RCT

Details and patient eligibility

About

To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

Full description

To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

Enrollment: 36 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pregnant women less than 20 weeks' gestation who had at least one prior spontaneous preterm birth of a liveborn baby between 20 & 0/7 weeks' and 36 & 6/7 weeks' gestation.

Exclusion criteria

• multiple gestations, the presence of major fetal anomalies, progesterone use in the current pregnancy (ongoing or past), the presence of a cervical cerclage, and the presence of a placenta previa.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Progesterone Group

Experimental group

Description:

Oral Micronized Progesterone

Treatment:

Drug: oral micronized progesterone

Placebo

Placebo Comparator group

Description:

Identical Placebo Tablet

Treatment:

Drug: Identical Placebo tablet