Oral Versus Parental Progesterone in the Management of Preterm Labor

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03343795

Enrollment

Registered

2017-11-17

Start date

2017-07-05

Completion date

2018-05-30

Last updated

2018-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Labor

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%)

Interventions

DRUGoral progesterone

daily

DRUGintramuscular progesterone

every week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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 .

Design outcomes

Primary

Measure	Time frame	Description
the rate of preterm labor	10 weeks	number of women delivered before 37 weeks

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026