Does using progesterone reduce the miscarriage rate in high risk pregnancies?

In pregnant women with previous subfertility, does progesterone supplementation decrease the likelihood of miscarriage?

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000401954

Acronym

Pregnancy Maintenance Trial (PMTrial)

Enrollment

197

Registered

2011-04-18

Start date

2012-01-20

Completion date

Unknown

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project will assess the effect of progesterone therapy on pregnancy outcomes in women previously diagnosed with subfertility. It is hypothesised that progesterone supplementation in early pregnancy decreases the likelihood of miscarriage, and potentially late pregnancy complications in women with previous subfertility.

Interventions

Progesterone pessary 400 mg, nightly until 12 weeks and 0 days, must be recruited prior to 7 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Previously diagnosed with subfertility (no pregnancy after 12 months random unprotected intercourse, a history of 3 or more miscarriages, failing to achieve an ongoing pregnancy after 12 months of random unprotected intercourse) 2. Pregnancy less than 7 weeks + 0 days

Exclusion criteria

Women who are pregnant as a result of Assisted Reproductive Technologies

Outcome results