Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies? - Full Text View

Purpose

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.

Condition	Intervention	Phase
Preterm Delivery	Drug: Progesterone Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial

Resource links provided by NLM:

Drug Information available for: Progesterone

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physical and neurological development of the children at 6 and 18 months [ Time Frame: 2 years after delivery ] [ Designated as safety issue: Yes ]
The relationship between cervical length and prophylactic progesterone treatment [ Time Frame: Participants will be followed until 3 weeks after delivery ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Assessment of the potential anti-inflammatory effect of progesterone by cytokine-measurements [ Time Frame: Participants will be followed until 3 weeks after delivery ] [ Designated as safety issue: No ]
Assessment of the effect of progesterone on CRH-levels in twin pregnancies [ Time Frame: Participants will be followed until 3 weeks after delivery ] [ Designated as safety issue: No ]

Enrollment:	677
Study Start Date:	June 2006
Study Completion Date:	September 2010
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo Placebo pessaries containing peanut oil Other Name: Placebo
Active Comparator: Progesterone	Drug: Progesterone Vaginal pessaries, 200 mg/day Other Name: Utrogestan

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329914

Locations

Austria
Graz University Hospital
Graz, Austria, 8036
Innsbruck University Hospital
Innsbruck, Austria, 6020
Klagenfurt Hospital
Klagenfurt, Austria, 9020
Vienna University Hospital
Vienna, Austria, 1090
Denmark
Aalborg Hospital
Aalborg, Denmark, 9100
Skejby Hospital
Aarhus, Denmark, 8200
Rigshospitalet
Copenhagen, Denmark, 2100
Glostrup Hospital
Glostrup, Denmark, 2600
Gentofte Hospital
Hellerup, Denmark, 2900
Herlev Hospital
Herlev, Denmark, 2730
Hilleroed Hospital
Hilleroed, Denmark, 3400
Holbaek Hospital
Holbaek, Denmark, 4300
Hvidovre Hospital
Hvidovre, Denmark, 2650
Odense University Hospital
Odense, Denmark, 5000
Roskilde Hospital
Roskilde, Denmark, 4000
Soenderborg Hospital
Soenderborg, Denmark, 6400
Viborg Hospital
Viborg, Denmark, 8800

Sponsors and Collaborators

Rigshospitalet, Denmark

The Danish Medical Research Council

The Danish Medical Society in Copenhagen

AP Moeller Foundation

Investigators

Principal Investigator:	Line Rode, MD	Ultrasound Clinic 4002, Rigshospitalet
Study Director:	Ann Tabor, professor	Ultrasound Clinic 4002, Rigshospitalet

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Rode L, Klein K, Nicolaides K, Krampl-Bettelheim E, Tabor A; PREDICT Group. Prevention of preterm delivery in twin gestations (PREDICT): A multicentre randomised placebo-controlled trial on the effect of vaginal micronised progesterone. Ultrasound Obstet Gynecol. 2011 Jul 7; [Epub ahead of print]

Klein K, Rode L, Nicolaides K, Krampl-Bettelheim E, Tabor A; PREDICT Group. Vaginal micronized progesterone and the risk of preterm delivery in high-risk twin pregnancies - secondary analysis of a placebo-controlled randomized trial and meta-analysis. Ultrasound Obstet Gynecol. 2011 Jul 7; [Epub ahead of print]

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rode L, Klein K, Larsen H, Holmskov A, Andreasen KR, Uldbjerg N, Ramb J, Bødker B, Skibsted L, Sperling L, Hinterberger S, Krebs L, Zingenberg H, Weiss EC, Strobl I, Laursen L, Christensen JT, Skogstrand K, Hougaard DM, Krampl-Bettelheim E, Rosthøj S, Vogel I, Tabor A. Cytokines and the risk of preterm delivery in twin pregnancies. Obstet Gynecol. 2012 Jul;120(1):60-8.

Responsible Party:	Professor Ann Tabor, Rigshospitalet
ClinicalTrials.gov Identifier:	NCT00329914 History of Changes
Other Study ID Numbers:	predict2006
Study First Received:	May 24, 2006
Last Updated:	July 22, 2011
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:

Preterm delivery
Prevention
Twins
Progesterone

Additional relevant MeSH terms:

Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone

Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013