Does using progesterone in threatened miscarriage increase the live birth rate?

In women with threatened miscarriage, does progesterone supplementation increase the likelihood of live birth?

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000405910

Acronym

Supporting Threatened Outcomes with Progesterone (STOP trial)

Enrollment

279

Registered

2011-04-19

Start date

2012-02-08

Completion date

2019-03-29

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 presenting with threatened miscarriage. It is hypothesised that progesterone supplementation for early threatened pregnancy increases the live birth rate.

Interventions

Progesterone pessary 400 mg nightly, until 12 weeks + 0 days

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Threatened miscarriage Live intra-uterine pregnancy Gestation less than 10 weeks + 0 days

Exclusion criteria

Pregnancy as a result of Assisted Reproductive Technologies

Outcome results