Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00536003

Acronym

Enrollment

384

Registered

2007-09-27

Start date

2006-07-31

Completion date

2012-12-31

Last updated

2012-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbidity, Perinatal Mortality, Preterm Delivery

Keywords

preterm delivery, preterm labor, perinatal morbidity, perinatal mortality

Brief summary

The administration of vaginal progesterone, in addition to standard tocolysis, will decrease the risk of delivering prematurely and of recurrent preterm labor. We also hypothesize that the reduction in preterm delivery will be associated with a decrease in infant mortality and morbidity.

Detailed description

The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation. Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces infant mortality and morbidity.

Interventions

DRUGprogesterone

vaginal capsules containing 200 mg of natural progesterone, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).

DRUGplacebo

vaginal capsules containing placebo, once a day, until 36 6/7 weeks of gestation or until preterm delivery (whichever occurs first).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Gestational age between 240/7 et 336/7 weeks of gestation (based on a reliable estimate by ultrasound performed before 22 weeks) * Singleton pregnancy * Intact membranes * Preterm labor defined as: * 2 or more regular and painful uterine contractions in 10 minutes plus one or plus of the following criteria: * short cervix detected by vaginal ultrasound scanning (cervical length less than 30 mm until 31 weeks and less than 25 mm from 32 weeks) * cervical changes detected clinically (cervical length less or equal 10 mm or Bishop score less than 6 * cervical changes during hospitalization (more or equal 5 mm between two clinical or US exams) * positive fetal fibronectin * Age ≥ 18 years old * Signed informed consent * Possible and accepted follow-up

Exclusion criteria

* Multiple gestation * Cervical cerclage * Hydramnios (AFI \>95th percentile for gestational age or greatest pocket \>8 cm) * Premature rupture of membranes * Chorioamnionitis (criteria for clinical diagnosis are: elevated WBC, elevated CRP, maternal tachycardia, fetal tachycardia, uterine tenderness and/or amniotic fluid foul odor) * Cervical dilatation \> 3 cm * Placenta praevia or abruptio placentae * Intra-uterine growth restriction or non-reassuring fetal status * Pre-eclampsia or severe hypertension * Any other maternal or fetal pathology which should indicate medically preterm delivery

Design outcomes

Primary

Measure	Time frame
The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation	end of pregnancy

Secondary

Measure	Time frame
Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces perinatal mortality and morbidity, 4)Side effects	end of pregnancy and 28 days after delivery

Countries

Argentina, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026