Vaginal Progesterone for the Prevention of Preterm Birth in Twins

• Status: Withdrawn
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This trial is a randomised, multi-centre, 2 x 2 factorial designed pilot trial with two factors of 200mg vs. 400mg progesterone self-administered daily from 11-14 weeks' gestation vs. 20-24 weeks' gestation, to compare the median gestational age (in days) at delivery between the comparison groups.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chiu Yee Liona Poon
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Age > 18 years

• Dichorionic diamniotic (DCDA) pregnancies

• Live fetuses at 11-13 weeks of gestation,

• Informed and written consent

Exclusion Criteria:

• High-risk for aneuploidies,

• Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks or 20-24 weeks assessment,

• Hypersensitivity to progesterone,

• Women taking progesterone regularly or at any time within the previous 7 days,

• Concurrent participation in another drug trial or at any time within the previous 28 days,

• Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness,

• Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.