Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01670929

Enrollment

700

Registered

2012-08-22

Start date

2012-09-30

Completion date

2015-11-30

Last updated

2016-04-05

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

Conditions

Abortion, Habitual

Keywords

recurrent miscarriages, progesterone

Brief summary

In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice daily), started soon as possible at luteal phase and after a positive pregnancy test and continued to 28 weeks of gestation, compared to placebo, ).

Detailed description

Progesterone improves secondary outcomes such as gestation at delivery, on-going pregnancy at 12 weeks, survival at 28 days of neonatal life. . Progesterone, compared to placebo, does not incur substantial adverse effects to the mother or the neonate. Explore differential or subgroup effects of progesterone in prognostic subgroups. . Perform an economic evaluation for cost-effectiveness.

Interventions

DRUGProgesterone

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 39 Years

Healthy volunteers

Inclusion criteria

1. Women with unexplained recurrent miscarriages (2 or more consecutive first trimester miscarriages). 2. Age 18-39 years at randomisation (likelihood of miscarriages due to chromosomal aberrations is higher in older women; such miscarriages are unlikely to be prevented by progesterone therapy). 3. Spontaneous conception (as confirmed by urinary pregnancy tests). 4. Willing and able to give informed consent.

Exclusion criteria

1. Age less than twenty or above forty years old. 2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice) 3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy). 4. Fibroids distorting uterine cavity. 5. Abnormal parental karyotype. 6. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).

Design outcomes

Primary

Measure	Time frame
Number of patients continued the pregnancy beyond 20 weeks gestation.	2 years

Secondary

Measure	Time frame
Number of miscarriages	2 years

Other

Measure	Time frame
Number of Live Birth	2 years
Number of preterm delivery	2 years

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026