Completed

Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Progesterone

+ Placebo

DrugOther
Who is being recruted

Abortion, Spontaneous+2

+ Urogenital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

From 20 to 39 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorWoman's Health University Hospital, Egypt
Last updated: April 5, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01670929
Principal SponsorWoman's Health University Hospital, Egypt
Last updated: April 5, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

700 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 20 to 39 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Abortion, SpontaneousUrogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPregnancy ComplicationsAbortion, Habitual

Criteria

4 inclusion criteria required to participate
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
Women with unexplained recurrent miscarriages (2 or more consecutive first trimester miscarriages)
6 exclusion criteria prevent from participating
Abnormal parental karyotype
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)
Fibroids distorting uterine cavity
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
progesterone (400 mg pessary, once daily)

Group II

Placebo
Placebo (pessary, once daily)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Women's Health Hospital

Asyut, EgyptOpen Women's Health Hospital in Google Maps
CompletedOne Study Center