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NCT03343795 Clinical Trial

Oral Versus Parental Progesterone in the Management of Preterm Labor

Preterm Labor Clinical Trial

Official title:
Oral Versus Parental Progesterone in the Management of Preterm Labor

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03343795
Other study ID # PPTL
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 5, 2017
Est. completion date May 30, 2018

Study information
Verified date June 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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%)

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date May 30, 2018
Est. primary completion date May 13, 2018
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

1. Past history of one or more spontaneous preterm labor.

2. Singleton pregnancy.

3. Pregnancy of less than 20 weeks of gestation

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 .

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• oral progesterone
daily
• intramuscular progesterone
every week

Locations
Country Name City State
Egypt Assiut Faculty of Medicine Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary the rate of preterm labor number of women delivered before 37 weeks 10 weeks
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