Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

Phase 3

Terminated

• Conditions: Preterm Delivery; Morbidity; Perinatal Mortality
• Interventions: Drug: placebo; Drug: progesterone

• Registration Number: NCT00536003
• Lead Sponsor: begoña Martinez de Tejada

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-26
• Study First Posted: 2007-09-27
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 384

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	progesterone	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (33)

Hospital Interzonal Alberto Antranik Eurnekian; 🇦🇷 Buenos Aires, Alem 349, Ezeiza, Provincia de Buenos Aires, Argentina

Hospital Carlos G. Durand; 🇦🇷 Buenos Aires, Av. Diaz Velez 5044, Cuidad Autónoma de Buenos Aires, Argentina

Instituto Universitario CEMIC; 🇦🇷 Buenos Aires, Av. E. Galván 4102, Ciudad Autónoma de Buenos Aires, Argentina

Hospital Bernardino Rivadavia; 🇦🇷 Buenos Aires, Av. Las Heras 2670, Cuidad Autónoma de Buenos Aires, Argentina

Hospital Mariano y Luciano de la Vega; 🇦🇷 Buenos Aires, Av. Libertador 710, Moreno, Provincia de Buenos Aires, Argentina

Hospital Maternidad Nuestra Señora De Las Mercedes; 🇦🇷 Buenos Aires, Av. Mate de Luna 1555, Provincia de Tucumán, Argentina

Hospital Villa Dolores; 🇦🇷 Buenos Aires, Belgrano 1500, Villa Dolores, Provincia de Códoba, Argentina

Hospital J. B. Iturraspe; 🇦🇷 Buenos Aires, Bvd. Pellegrini 3551, Provincia de Santa Fe, Argentina

Hospital Comunal de Tigre; 🇦🇷 Buenos Aires, Casareto 118, Tigre, Provincia de Buenos Aires, Argentina

Hospital Materno Infantil de San Isidro; 🇦🇷 Buenos Aires, Diego Palma 505, San Isidro, Provincia de Buenos Aires, Argentina

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