Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

Abortion, Habitual Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670929
• Other study ID #: PPROURM
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2012
• Last updated: April 3, 2016
• Start date: September 2012
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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, ).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: November 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Habitual

Intervention

Drug:
• Progesterone

Other:
• Placebo

Locations

Country	Name	City	State
Egypt	Women's Health Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Live Birth		2 years	Yes
Other	Number of preterm delivery		2 years	Yes
Primary	Number of patients continued the pregnancy beyond 20 weeks gestation.		2 years	Yes
Secondary	Number of miscarriages		2 years	Yes