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Preconceptional Progesterone Treatment in Women With Unexplained Recurrent Miscarriage, A Randomized Double-blind Controlled Trial

This study is currently recruiting participants.
Verified August 2012 by Woman's Health University Hospital, Egypt
Sponsor:
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier:
NCT01670929
First received: August 17, 2012
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

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 32 weeks of gestation, compared to placebo, increases live births beyond 32 completed weeks by at least 10% (principal objective).


Condition Intervention Phase
Abortion, Habitual
 Drug: Progesterone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Preconceptionalprogesterone in Patients With Recurrent Unexplained Miscarriages

Resource links provided by NLM:

MedlinePlus related topics: Miscarriage
U.S. FDA Resources

Further study details as provided by Woman's Health University Hospital, Egypt:

Primary Outcome Measures:
  • Live births beyond 32 weeks [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    progesterone (400 mg pessaries, twice daily), started soon as possible at luteal phase and after a positive pregnancy test and continued to 32 weeks of gestation.


Secondary Outcome Measures:
  • Gestation at delivery and fetal weight AND Congenital abnormalities with specific examination for genital anomalies [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Gestation at delivery and fetal weight Doppler changes in both groups. Survival at 32 days of neonatal life


Other Outcome Measures:
  • Clinical pregnancy at 6-8 weeks. . On-going pregnancy at 12 weeks (range 11-13 weeks). . Miscarriage rate. .Doppler changes in both groups. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    Clinical pregnancy at 6-8 weeks.

    • On-going pregnancy at 12 weeks (range 11-13 weeks).
    • Miscarriage rate. .Doppler changes in both groups.


Estimated Enrollment: 400
Study Start Date: January 2011
Estimated Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: progesterone
progesterone (400 mg pessaries, twice daily)
 Drug: Progesterone
progesterone either vaginal or rectal rout twice daily
Other Names:
  • prontogest
  • cyclogest

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670929

Contacts
Contact: Alaa M Ismail, M D +201000259514 dr.alaa_ismail@yahoo.com
Contact: Hassan S Kamel, M D hkamehkamel@yahoo.com

Locations
Egypt
Women's Health Hospital Recruiting
Assiut, Egypt
Contact: Hassan S Kamel, M D         hkamelhkamel@yahoo.com    
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
Principal Investigator: Alaa M Ismail, M D Faculity of medicine,Assiut university
  More Information

No publications provided

Responsible Party: alaa eldeen mahmoud ismail, M D, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT01670929     History of Changes
Other Study ID Numbers: PPROURM
Study First Received: August 17, 2012
Last Updated: August 21, 2012
Health Authority: Egypt: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Woman's Health University Hospital, Egypt:
recurrent miscarriages
progesterone

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Progesterone
Progestins
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013