Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?

Preterm Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329914
• Other study ID #: predict2006
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2006
• Last updated: July 22, 2011
• Start date: June 2006
• Est. completion date: September 2010

Study information

• Verified date: February 2009
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 677
• Est. completion date: September 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

• Premature Birth
• Preterm Delivery

Intervention

Drug:
• Progesterone
Vaginal pessaries, 200 mg/day
• Placebo
Placebo pessaries containing peanut oil

Locations

Country	Name	City	State
Austria	Graz University Hospital	Graz
Austria	Innsbruck University Hospital	Innsbruck
Austria	Klagenfurt Hospital	Klagenfurt
Austria	Vienna University Hospital	Vienna
Denmark	Aalborg Hospital	Aalborg
Denmark	Skejby Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Glostrup Hospital	Glostrup
Denmark	Gentofte Hospital	Hellerup
Denmark	Herlev Hospital	Herlev
Denmark	Hilleroed Hospital	Hilleroed
Denmark	Holbaek Hospital	Holbaek
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Odense University Hospital	Odense
Denmark	Roskilde Hospital	Roskilde
Denmark	Soenderborg Hospital	Soenderborg
Denmark	Viborg Hospital	Viborg

Sponsors (4)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	AP Moeller Foundation, The Danish Medical Research Council, The Danish Medical Society in Copenhagen

Countries where clinical trial is conducted

Austria,  Denmark, 

References & Publications (2)

Klein K, Rode L, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Vaginal micronized progesterone and risk of preterm delivery in high-risk twin pregnancies: secondary analysis of a placebo-controlled randomized trial and meta-analysis. Ultraso — View Citation

Rode L, Klein K, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Prevention of preterm delivery in twin gestations (PREDICT): a multicenter, randomized, placebo-controlled trial on the effect of vaginal micronized progesterone. Ultrasound Obst — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of delivery < 34 weeks, in the study group versus the control group		Participants will be followed until 3 weeks after delivery	No
Secondary	Physical and neurological development of the children at 6 and 18 months		2 years after delivery	Yes
Secondary	The relationship between cervical length and prophylactic progesterone treatment		Participants will be followed until 3 weeks after delivery	No
Secondary	Determination of proteomics and RNA in preterm delivery and term delivery and an evaluation of the effect of progesterone on proteomics and RNA		Participants will be followed until 3 weeks after delivery	No
Secondary	Assessment of the potential anti-inflammatory effect of progesterone by cytokine-measurements		Participants will be followed until 3 weeks after delivery	No
Secondary	Assessment of the effect of progesterone on CRH-levels in twin pregnancies		Participants will be followed until 3 weeks after delivery	No

External Links

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