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Clinical Trials/NCT02329535
NCT02329535
Terminated
Not Applicable

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

HaEmek Medical Center, Israel2 sites in 1 country15 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Micronized progesterone
Conditions
Premature Birth
Sponsor
HaEmek Medical Center, Israel
Enrollment
15
Locations
2
Primary Endpoint
Preterm delivery
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
August 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Noah Zafran

Senion physician OB-GYN

HaEmek Medical Center, Israel

Eligibility Criteria

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)

Arms & Interventions

Treatment group

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

Intervention: Micronized progesterone

Outcomes

Primary Outcomes

Preterm delivery

Time Frame: up to 25 weeks from randomization

Rate of preterm delivery before 37.

Study Sites (2)

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