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Clinical Trials/NCT03343795
NCT03343795
Completed
Phase 4

Oral Versus Parental Progesterone in the Management of Preterm Labor

Assiut University1 site in 1 country80 target enrollmentJuly 5, 2017

Overview

Phase
Phase 4
Intervention
oral progesterone
Conditions
Preterm Labor
Sponsor
Assiut University
Enrollment
80
Locations
1
Primary Endpoint
the rate of preterm labor
Status
Completed
Last Updated
7 years ago

Overview

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%)

Registry
clinicaltrials.gov
Start Date
July 5, 2017
End Date
May 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed Abbas

Principal investigator

Assiut University

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 .

Arms & Interventions

study group 1

oral progesterone

Intervention: oral progesterone

study group 2

intramuscular progesterone

Intervention: intramuscular progesterone

Outcomes

Primary Outcomes

the rate of preterm labor

Time Frame: 10 weeks

number of women delivered before 37 weeks

Study Sites (1)

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