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Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

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ClinicalTrials.gov Identifier: NCT01670929
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt

Study Description
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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, ).

Condition or disease Intervention/treatment Phase
Abortion, Habitual Drug: Progesterone Other: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Progesterone group
progesterone (400 mg pessary, once daily)
 Drug: Progesterone
Placebo Comparator: Placebo group
Placebo (pessary, once daily)
 Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients continued the pregnancy beyond 20 weeks gestation. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Number of miscarriages [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Number of Live Birth [ Time Frame: 2 years ]
  2. Number of preterm delivery [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670929


Locations
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Egypt
Women's Health Hospital
Assiut, Egypt
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
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Principal Investigator: Alaa M Ismail, M D Faculity of medicine,Assiut university
More Information
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Responsible Party: alaa eldeen mahmoud ismail, M D, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT01670929    
Other Study ID Numbers: PPROURM
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016
Keywords provided by alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt:
recurrent miscarriages
progesterone
Additional relevant MeSH terms:
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Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications
Progesterone
 Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs