Back to resultsOral Versus Parental Progesterone in the Management of Preterm Labor
Primary Purpose
Preterm Labor
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
oral progesterone
intramuscular progesterone
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Labor
Eligibility Criteria
Inclusion Criteria:
- Past history of one or more spontaneous preterm labor.
- Singleton pregnancy.
- Pregnancy of less than 20 weeks of gestation
Exclusion Criteria:
- Women on tocolytic drugs .
- Underwent cervical cerclage in this pregnancy .
- Multiple gestations .
- Major fetal congenital malformations .
- Pregnancy 0f more than 20 weeks gestation .
Sites / Locations
- Assiut Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group 1
study group 2
Arm Description
oral progesterone
intramuscular progesterone
Outcomes
Primary Outcome Measures
the rate of preterm labor
number of women delivered before 37 weeks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03343795
Brief Title
Oral Versus Parental Progesterone in the Management of Preterm Labor
Official Title
Oral Versus Parental Progesterone in the Management of Preterm Labor
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
May 13, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Preterm birth, defined as delivery at less than 37 weeks gestation, complicates approximately 12% of pregnancies in the United States
Preterm delivery has been, and remains, the most important challenge to modern obstetrics. In 2009, 13 million babies were born preterm, 11 million in Africa and Asia and 500,000 in the USA, The highest rates of preterm birth are in Africa (11.9%) and North America (10.6%)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group 1
Arm Type
Experimental
Arm Description
oral progesterone
Arm Title
study group 2
Arm Type
Active Comparator
Arm Description
intramuscular progesterone
Intervention Type
Drug
Intervention Name(s)
oral progesterone
Intervention Description
daily
Intervention Type
Drug
Intervention Name(s)
intramuscular progesterone
Intervention Description
every week
Primary Outcome Measure Information:
Title
the rate of preterm labor
Description
number of women delivered before 37 weeks
Time Frame
10 weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Past history of one or more spontaneous preterm labor.
Singleton pregnancy.
Pregnancy of less than 20 weeks of gestation
Exclusion Criteria:
Women on tocolytic drugs .
Underwent cervical cerclage in this pregnancy .
Multiple gestations .
Major fetal congenital malformations .
Pregnancy 0f more than 20 weeks gestation .
Facility Information:
Facility Name
Assiut Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Oral Versus Parental Progesterone in the Management of Preterm Labor
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