Oral Versus Parental Progesterone in the Management of Preterm Labor

Phase 4

Completed

• Conditions: Preterm Labor
• Interventions: Drug: oral progesterone; Drug: intramuscular progesterone

• Registration Number: NCT03343795
• Lead Sponsor: Assiut University

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%)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-05
• Study First Submitted: 2017-11-11
• Study First Submitted QC: 2017-11-11
• Study First Posted: 2017-11-17
• Primary Completion: 2018-05-13
• Study Completion: 2018-05-30
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Past history of one or more spontaneous preterm labor.
2. Singleton pregnancy.
3. Pregnancy of less than 20 weeks of gestation

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Exclusion Criteria

1. Women on tocolytic drugs .
2. Underwent cervical cerclage in this pregnancy .
3. Multiple gestations .
4. Major fetal congenital malformations .
5. Pregnancy 0f more than 20 weeks gestation .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group 1	oral progesterone	oral progesterone
study group 2	intramuscular progesterone	intramuscular progesterone

Primary Outcome Measures

Name	Time	Method
the rate of preterm labor	10 weeks	number of women delivered before 37 weeks

Trial Locations

Locations (1)

Assiut Faculty of Medicine; 🇪🇬 Assiut, Egypt