Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

Woman's Health University Hospital, Egypt

Status and phase: Completed; Phase 4

Conditions: Abortion, Habitual

Treatments: Other: Placebo; Drug: Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT01670929

PPROURM

Details and patient eligibility

About

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, ).

Full 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.

Enrollment: 700 patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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700 participants in 2 patient groups, including a placebo group

Progesterone group

Active Comparator group

Description:

progesterone (400 mg pessary, once daily)

Treatment:

Drug: Progesterone

Placebo group

Placebo Comparator group

Description:

Placebo (pessary, once daily)

Treatment:

Other: Placebo