Comparing IM vs. Vaginal Progesterone for Pre-term Birth

NCT ID: NCT00579553

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2011-05-31

Brief 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.

Detailed 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.

Conditions

Infant, Premature; Premature Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intramuscular Progesterone

Intramuscular Progesterone

Group Type: ACTIVE_COMPARATOR

Intramuscular Progesterone

Intervention Type: DRUG

Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P

Vaginal Progesterone

Vaginal Progesterone

Group Type: EXPERIMENTAL

Vaginal Progesterone

Intervention Type: DRUG

Vaginal Progesterone: 100 mg vaginal suppository daily

Interventions

Intramuscular Progesterone

Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P

Intervention Type: DRUG

Vaginal Progesterone

Vaginal Progesterone: 100 mg vaginal suppository daily

Intervention Type: DRUG

Other Intervention Names

17 alpha hydroxyprogesterone caproate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Elimian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

References

Elimian A, Smith K, Williams M, Knudtson E, Goodman JR, Escobedo MB. A randomized controlled trial of intramuscular versus vaginal progesterone for the prevention of recurrent preterm birth. Int J Gynaecol Obstet. 2016 Aug;134(2):169-72. doi: 10.1016/j.ijgo.2016.01.010. Epub 2016 Apr 18.

Reference Type: DERIVED

PMID: 27168167 (View on PubMed)

Other Identifiers

Progesterone75,643

Identifier Type: -

Identifier Source: org_study_id