Comparing IM vs. Vaginal Progesterone for Pre-term Birth

Premature Birth Clinical Trial

Official title:

Comparing Intramuscular Versus Vaginal Progesterone for Prevention of Preterm Birth.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579553
• Other study ID #: Progesterone75,643
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Est. completion date: May 2011

Study information

• Verified date: April 2021
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes.

Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.

Description:

This study is intended as a randomized controlled trial. Women with singleton pregnancies between 16 and 20 weeks 6 day will be randomized to one of two treatment groups.

Those randomized to weekly intramuscular progesterone will receive 250 mg of 17 alpha hydroxyprogesterone caproate every week in the clinic between randomization and delivery for those delivery preterm or 36 weeks 6 days.

While those randomized to vaginal progesterone will receive 100 mg vaginal progesterone daily at home. Vaginal progesterone to last between clinic visits will be provided to subject. Those women in the vaginal progesterone group will also be informed on how to obtain additional medication in case of missed clinic appointment. Treatment will be continued until 36 weeks 6 days or as dictated by date of preterm delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancies

• History of spontaneous preterm brith (between 20 weeks and 36 weeks 6 days)

• Gestational age between 16 weeks 0 days and 20 weeks 6 days.

• Signed consent to participate in the trial

Exclusion Criteria:

• Multiple Gestation

• Prior elective fetal reduction or planned termination

• Known spontaneous reduction to singleton

• Major fetal anomaly or known fetal chromosomal abnormalities

• Progesteone used this pregnancy

Related Conditions & MeSH terms

• Infant, Premature
• Premature Birth

Intervention

Drug:
• Intramuscular Progesterone
Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P
• Vaginal Progesterone
Vaginal Progesterone: 100 mg vaginal suppository daily

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm Birth	Delivery before 37 weeks gestation.	From 16-20 weeks gestation through preterm delivery
Secondary	Preterm Birth	Delivery below 34 weeks gestation	From 16-20 weeks gestation through preterm delivery
Secondary	Gestational Age at Delivery	Mean gestational age at delivery	From 16-20 weeks gestation through preterm delivery
Secondary	Mean Neonatal Birth Weight		At delivery