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OpenTrials
Completed

NCT Number: NCT03343795

Oral Versus Parental Progesterone in the Management of Preterm Labor

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%)

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Assiut Faculty of Medicine

Asyut, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

oral progesterone

Drug

daily

Intramuscular Progesterone

Drug

every week

Primary outcomes

  1. the rate of preterm labor

    Time frame: 10 weeks

    number of women delivered before 37 weeks

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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