Oral Versus Parental Progesterone in the Management of Preterm Labor

NCT ID: NCT03343795

Last Updated: 2018-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-05

Study Completion Date

2018-05-30

Brief Summary

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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

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Conditions

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Preterm Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group 1

oral progesterone

Group Type EXPERIMENTAL

oral progesterone

Intervention Type DRUG

daily

study group 2

intramuscular progesterone

Group Type ACTIVE_COMPARATOR

intramuscular progesterone

Intervention Type DRUG

every week

Interventions

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oral progesterone

daily

Intervention Type DRUG

intramuscular progesterone

every week

Intervention Type DRUG

Eligibility Criteria

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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 .
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PPTL

Identifier Type: -

Identifier Source: org_study_id

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