Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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, ).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vaginal Progesterone for Treatment of Threatened Miscarriage

NCT02690129

Threatened Miscarriage

UNKNOWN NA

Progesterone in Threatened Abortion

NCT02950935

Threatened Abortion in First Trimester

TERMINATED PHASE3

Oral Progesterone for Prevention of Miscarriage in Threatened Abortion

NCT04788108

Threatened Abortion

COMPLETED PHASE4

Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage

NCT03628625

Miscarriage Missed Abortion

UNKNOWN PHASE2

Progesterone Supplementation in Threatened Abortion

NCT03930212

Threatened Abortion Progesterone Resistance

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abortion, Habitual

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Progesterone group

progesterone (400 mg pessary, once daily)

Group Type ACTIVE_COMPARATOR

Progesterone

Intervention Type DRUG

Placebo group

Placebo (pessary, once daily)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Progesterone

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No