NCT00579553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
10.1 years until next milestone

Results Posted

Study results publicly available

May 19, 2021

Completed
Last Updated

May 19, 2021

Status Verified

April 1, 2021

Enrollment Period

4.6 years

First QC Date

December 18, 2007

Results QC Date

October 15, 2020

Last Update Submit

April 28, 2021

Conditions

Infant, PrematurePremature Birth

Keywords

Pre TermPre Term BirthPremature BirthPremature babyHigh risk pregnancyProgesteroneIM ProgesteroneVaginal Progesterone

Outcome Measures

Primary Outcomes (1)

  • Preterm Birth

    Delivery before 37 weeks gestation.

    From 16-20 weeks gestation through preterm delivery

Secondary Outcomes (3)

  • Preterm Birth

    From 16-20 weeks gestation through preterm delivery

  • Gestational Age at Delivery

    From 16-20 weeks gestation through preterm delivery

  • Mean Neonatal Birth Weight

    At delivery

Study Arms (2)

Intramuscular Progesterone

ACTIVE COMPARATOR

Intramuscular Progesterone

Drug: Intramuscular Progesterone

Vaginal Progesterone

EXPERIMENTAL

Vaginal Progesterone

Drug: Vaginal Progesterone

Interventions

Intramuscular ProgesteroneDRUG

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

Also known as: 17 alpha hydroxyprogesterone caproate
Intramuscular Progesterone
Vaginal ProgesteroneDRUG

Vaginal Progesterone: 100 mg vaginal suppository daily

Vaginal Progesterone

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • 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.

    PMID: 27168167DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

17 alpha-Hydroxyprogesterone Caproate

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

17-alpha-HydroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsProgesterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Andrew Elimian, MD
Organization
University of Oklahoma Health Science Center
aelimian@aol.com
19146465194

Study Officials

  • Andrew Elimian, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 24, 2007

Study Start

October 1, 2006

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 19, 2021

Results First Posted

May 19, 2021

Record last verified: 2021-04

Locations

US(1)