Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00329914|
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : July 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Preterm Delivery||Drug: Progesterone Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||677 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||September 2010|
|Placebo Comparator: Placebo||
Placebo pessaries containing peanut oil
|Active Comparator: Progesterone||
Vaginal pessaries, 200 mg/day
Other Name: Utrogestan
- The incidence of delivery < 34 weeks, in the study group versus the control group [ Time Frame: Participants will be followed until 3 weeks after delivery ]
- Physical and neurological development of the children at 6 and 18 months [ Time Frame: 2 years after delivery ]
- The relationship between cervical length and prophylactic progesterone treatment [ Time Frame: Participants will be followed until 3 weeks after delivery ]
- Determination of proteomics and RNA in preterm delivery and term delivery and an evaluation of the effect of progesterone on proteomics and RNA [ Time Frame: Participants will be followed until 3 weeks after delivery ]
- Assessment of the potential anti-inflammatory effect of progesterone by cytokine-measurements [ Time Frame: Participants will be followed until 3 weeks after delivery ]
- Assessment of the effect of progesterone on CRH-levels in twin pregnancies [ Time Frame: Participants will be followed until 3 weeks after delivery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329914
|Principal Investigator:||Line Rode, MD||Ultrasound Clinic 4002, Rigshospitalet|
|Study Director:||Ann Tabor, professor||Ultrasound Clinic 4002, Rigshospitalet|