Overview

Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rigshospitalet, Denmark
Collaborators:
AP Moeller Foundation
The Danish Medical Research Council
The Danish Medical Society in Copenhagen
Treatments:
Progesterone
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