Oral Versus Parental Progesterone in the Management of Preterm Labor

Assiut University

Status and phase: Completed; Phase 4

Conditions: Preterm Labor

Treatments: Drug: intramuscular progesterone; Drug: oral progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT03343795

PPTL

Details and patient eligibility

About

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%)

Enrollment: 80 patients

Sex: Female

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

study group 1

Experimental group

Description:

oral progesterone

Treatment:

Drug: oral progesterone

study group 2

Active Comparator group

Description:

intramuscular progesterone

Treatment:

Drug: intramuscular progesterone