Clinical Trials Logo

Clinical Trial Summary

The purpose of the study is to determine whether a daily dose of 200 mg progesterone administered vaginally from 20-23 to 34 weeks' gestation will reduce the rate of preterm delivery amongst twin pregnancies.


Clinical Trial Description

Multiple gestations account for 2% of all pregnancies, but cause more than 10% of the cases of preterm delivery. Due to increasing maternal age and use of assisted reproduction the number of multiple gestations is larger than ever. If markers of preterm delivery can be identified and means of preventing preterm delivery are found, it will be possible to reduce the number of children admitted to hospital because of prematurity.

Recently, two larger randomised studies investigated the effect of progesterone in singleton pregnancies of women who had previously delivered preterm. They both found a significant reduction in the preterm delivery rate in the progesterone group compared to a placebo group.

The study will be performed as a randomized, double-blind placebo controlled study of twin pregnancies in Denmark and Austria. The women will be randomised in a 1:1 ratio to two groups (progesterone versus placebo). Randomisation will be stratified per centre and according to chorionicity, as the risk of preterm delivery is doubled in monochorionic twins compared to dichorionic twins. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00329914
Study type Interventional
Source Rigshospitalet, Denmark
Contact
Status Completed
Phase Phase 2
Start date June 2006
Completion date September 2010

See also
  Status Clinical Trial Phase
Completed NCT03304782 - Fitbit Activity Tracker to Predict Risk of Preterm Birth
Recruiting NCT02420743 - Serum Ferritin Concentration and Fetal MCA Doppler as Predictors for Preterm Delivery
Completed NCT01119963 - Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM) Phase 2/Phase 3
Completed NCT01665378 - Impact of Pre-pregnancy Micronutrient Supplementation on Maternal and Child Outcomes N/A
Completed NCT00141908 - Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate Phase 2
Recruiting NCT05278130 - Serial Screening and Treatment of Bacterial Vaginosis Trial N/A
Terminated NCT03596125 - Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP) Phase 2/Phase 3
Recruiting NCT03123926 - Spontaneous Preterm Birth Marker Test N/A
Completed NCT00201643 - A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome Phase 4
Completed NCT01353807 - Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health N/A
Terminated NCT02545127 - Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely Phase 2
Completed NCT02371356 - Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health
Active, not recruiting NCT01009723 - Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers N/A
Completed NCT00883324 - Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum N/A
Completed NCT00615550 - PREGNANT Short Cervix Trial Phase 3
Completed NCT02694679 - Randomized Controlled Trial of Social Network Targeting in Honduras N/A
Completed NCT01031017 - Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies Phase 4
Completed NCT00331695 - Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery Phase 4
Completed NCT01818518 - Neonatal Outcome by Reason for Delivery
Completed NCT04637880 - 25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders