Back to resultsPr-conceptional Progesterone for Unexplained Recurrent Miscarriage
Primary Purpose
Abortion, Habitual
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Progesterone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Abortion, Habitual focused on measuring recurrent miscarriages, progesterone
Eligibility Criteria
Inclusion Criteria:
- Women with unexplained recurrent miscarriages (2 or more consecutive first trimester miscarriages).
- 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).
- Spontaneous conception (as confirmed by urinary pregnancy tests).
- Willing and able to give informed consent.
Exclusion Criteria:
- Age less than twenty or above forty years old.
- Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice)
- Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
- Fibroids distorting uterine cavity.
- Abnormal parental karyotype.
- Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
Sites / Locations
- Women's Health Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Progesterone group
Placebo group
Arm Description
progesterone (400 mg pessary, once daily)
Placebo (pessary, once daily)
Outcomes
Primary Outcome Measures
Number of patients continued the pregnancy beyond 20 weeks gestation.
Secondary Outcome Measures
Number of miscarriages
Full Information
NCT ID
NCT01670929
First Posted
August 17, 2012
Last Updated
April 3, 2016
Sponsor
Woman's Health University Hospital, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT01670929
Brief Title
Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Woman's Health University Hospital, Egypt
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Habitual
Keywords
recurrent miscarriages, progesterone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Progesterone group
Arm Type
Active Comparator
Arm Description
progesterone (400 mg pessary, once daily)
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo (pessary, once daily)
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of patients continued the pregnancy beyond 20 weeks gestation.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of miscarriages
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Number of Live Birth
Time Frame
2 years
Title
Number of preterm delivery
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with unexplained recurrent miscarriages (2 or more consecutive first trimester miscarriages).
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).
Spontaneous conception (as confirmed by urinary pregnancy tests).
Willing and able to give informed consent.
Exclusion Criteria:
Age less than twenty or above forty years old.
Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice)
Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
Fibroids distorting uterine cavity.
Abnormal parental karyotype.
Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa M Ismail, M D
Organizational Affiliation
Faculity of medicine,Assiut university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Health Hospital
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage
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