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