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

This study has been completed.
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 4, 2014
Last verified: August 2014
  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 28 weeks of gestation, compared to placebo, ).


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 Preconceptional Progesterone in Patients With Recurrent Unexplained Miscarriages

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Ongoing pregnancy after 10 weeks (range 11-20 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 28 weeks of gestation.


Secondary Outcome Measures:
  • miscarriage rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    1. Miscarriage rate
    2. Live births beyond 28 weeks.
    3. Gestation at delivery and fetal weight.
    4. Congenital abnormalities with specific examination for genital anomalies.
    5. Adverse events.
    6. Antenatal complications such as pre-eclampsia, preterm labor, preterm pre-labor rupture of membranes and intrauterine growth restriction (IUGR).


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

    Clinical pregnancy at 6-8 weeks.

    • Ongoing pregnancy at 12 weeks (range 11-13 weeks).
    • Miscarriage rate.

  • Clinical pregnancy at 6-8 weeks. . Ongoing pregnancy at 12 weeks (range 11-13 weeks). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    Clinical pregnancy at 6-8 weeks.

    • Ongoing pregnancy at 12 weeks (range 11-13 weeks).
    • Miscarriage rate.


Enrollment: 400
Study Start Date: September 2012
Study Completion Date: March 2014
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670929

Locations
Egypt
Women's Health Hospital
Assiut, Egypt
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 4, 2014
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 August 28, 2014