Comparing Double Dose of Vaginal Progesterone to no Treatment for Prevention of Preterm Birth in Twins and Short Cervix

Not Applicable

Terminated

• Conditions: Premature Birth
• Interventions: Drug: Micronized progesterone

• Registration Number: NCT02329535
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

Twin pregnancies are more likely to be delivered preterm than singleton pregnancies. Vaginal progesterone administration (200 mg Utrogestan) to asymptomatic women with a singleton pregnancy and sonographic short cervix reduced the risk of preterm birth (PTB) and neonatal morbidity and mortality, yet not proved efficient in twins' pregnancy. The investigators' hypothesis is that a higher dose of vaginal micronized progesterone will be more effective in preventing PTD. The objectives of the study is to compare the rate of preterm birth and perinatal morbidity and mortality in a twin pregnancy with short cervical length treated with vaginal 400 mg of micronized progesterone to no treatment. The study is Randomized, open label, of twin pregnancy between 16-26 weeks of gestation with cervical length under 25 mm. Women will be randomly assigned to either treatment or no treatment group. Progesterone treatment will be given until 36 weeks of gestation. Other management will be according to standard protocol.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-30
• Study First Submitted QC: 2014-12-28
• Study First Posted: 2014-12-31
• Study Start: 2015-01
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Twin gestation
• Certain dating (documented first trimester ultrasound, or a reliable menstrual date confirmed by an ultrasound performed before 20 weeks of gestation)
• Age > 18 years
• Gestational age 16-26
• Cervical length<25 mm
• Intact membranes
• Informed consent

Exclusion Criteria

• Major malformation or chromosomal abnormality to at least one fetus
• Higher order pregnancy
• Mocochorional-monoamniotic twin
• Death of one fetus
• Cervical dilatation >3 cm
• Chronic medical conditions that would interfere with study participation or evaluation of the treatment (e.g. seizures, psychiatric disorders, uncontrolled chronic hypertension, congestive heart failure, chronic renal failure, uncontrolled diabetes mellitus with end-organ dysfunction, active thrombophlebitis or a thromboembolic disorder, history of hormone-associated thrombophlebitis or thromboembolic disorders, active liver dysfunction or disease, known or suspected malignancy of the breast or genital organs)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Micronized progesterone	Treatment with 400 mg Micronized progesterone (Utrogestan) daily up to 6 weeks of geastation

Primary Outcome Measures

Name	Time	Method
Preterm delivery	up to 25 weeks from randomization	Rate of preterm delivery before 37.

Trial Locations

Locations (2)

Haemek Medical Center; 🇮🇱 Afula, Israel

The Nazareth hospital; 🇮🇱 Nazareth, Israel