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Clinical trial

Progesterone Supplementation in Threatened Abortion: Is it a Sound Practice?

ID
Name
Prog133077
Description
To decide whether progesterone supplementation in threatened abortion is a sound practice.
Trial arms
Trial start
2018-01-01
Estimated PCD
2018-12-31
Trial end
2018-12-31
Status
Completed
Phase
Early phase I
Treatment
Progesterone
received rectal progesterone suppositories 400 mg once daily
Arms:
Progesterone
Placebos
received placebo suppositories rectally once daily.
Arms:
Control group
Size
190
Primary endpoint
relief of pain
3 weeks
completion of pregnancy beyond 20 weeks
12 weeks
Stoppage of bleeding
3 weeks
Eligibility criteria
Inclusion Criteria: * threatened abortion diagnosed by history and ultrasound examination * singleton * viable fetus * gestational age \< 20 weeks * closed normal length cervix. Exclusion Criteria: * short cervix \<2 cm Multiple pregnancy * dead fetus * open cervix ≥ 2cm * history of cervical surgery * refusal to participate.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 190, 'type': 'ACTUAL'}}
Updated at
2023-07-18

1 organization

2 products

2 indications

Organization
Tanta University
Product
Progesterone
Indication
Miscarriage
Indication
Progesterone Resistance
Product
Placebos