Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

Phase 4

Completed

• Conditions: Abortion, Habitual
• Interventions: Other: Placebo; Drug: Progesterone

• Registration Number: NCT01670929
• Lead Sponsor: Woman's Health University Hospital, Egypt

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.

Study Timeline

• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-22
• Study Start: 2012-09
• Primary Completion: 2015-05
• Study Completion: 2015-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-03
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 700

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Placebo (pessary, once daily)
Progesterone group	Progesterone	progesterone (400 mg pessary, once daily)

Primary Outcome Measures

Name	Time	Method
Number of patients continued the pregnancy beyond 20 weeks gestation.	2 years

Secondary Outcome Measures

Name	Time	Method
Number of miscarriages	2 years

Trial Locations

Locations (1)

Women's Health Hospital; 🇪🇬 Assiut, Egypt