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Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?

Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Delivery

Intervention: Progesterone (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Rigshospitalet, Denmark

Official(s) and/or principal investigator(s):
Line Rode, MD, Principal Investigator, Affiliation: Ultrasound Clinic 4002, Rigshospitalet
Ann Tabor, professor, Study Director, Affiliation: Ultrasound Clinic 4002, Rigshospitalet

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 Details

Official title: Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial

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

Primary outcome: The incidence of delivery < 34 weeks, in the study group versus the control group

Secondary outcome:

Physical and neurological development of the children at 6 and 18 months

The relationship between cervical length and prophylactic progesterone treatment

Determination of proteomics and RNA in preterm delivery and term delivery and an evaluation of the effect of progesterone on proteomics and RNA

Assessment of the potential anti-inflammatory effect of progesterone by cytokine-measurements

Assessment of the effect of progesterone on CRH-levels in twin pregnancies

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Twin pregnancy

- Informed consent

- 18-23 weeks' gestation

- Participants must be fluent in the language spoken in the respective centres

Exclusion Criteria:

- Age < 18 years

- Known allergy to progesterone or peanuts

- Active thromboembolic disorders or a history of hormone-associated thromboembolic

disorders

- Rupture of membranes at the time of inclusion

- Monoamniotic twins

- Pregnancies treated for or with signs of twin-to-twin transfusion syndrome at

inclusion

- Multiple pregnancies reduced to twin pregnancies

- Known significant structural or chromosomal fetal abnormality

- Chorionicity not assessed before 15 weeks

- Known or suspected malignancy in genitals or breasts

- Known liver disease

Locations and Contacts

Graz University Hospital, Graz 8036, Austria

Innsbruck University Hospital, Innsbruck 6020, Austria

Klagenfurt Hospital, Klagenfurt 9020, Austria

Vienna University Hospital, Vienna 1090, Austria

Aalborg Hospital, Aalborg 9100, Denmark

Skejby Hospital, Aarhus 8200, Denmark

Rigshospitalet, Copenhagen 2100, Denmark

Glostrup Hospital, Glostrup 2600, Denmark

Gentofte Hospital, Hellerup 2900, Denmark

Herlev Hospital, Herlev 2730, Denmark

Hilleroed Hospital, Hilleroed 3400, Denmark

Holbaek Hospital, Holbaek 4300, Denmark

Hvidovre Hospital, Hvidovre 2650, Denmark

Odense University Hospital, Odense 5000, Denmark

Roskilde Hospital, Roskilde 4000, Denmark

Soenderborg Hospital, Soenderborg 6400, Denmark

Viborg Hospital, Viborg 8800, Denmark

Additional Information

Starting date: June 2006
Last updated: July 22, 2011

Page last updated: August 23, 2015

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