Clinical trial NCT00579553: Comparing IM vs. Vaginal Progesterone for Pre-term Birth
Official title: Comparing Intramuscular Versus Vaginal Progesterone for Prevention of Preterm Birth.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Premature Birth
Keywords: Pre Term
Pre Term Birth
Premature Birth
Premature baby
High risk pregnancy
Progesterone
IM Progesterone
Vaginal Progesterone
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Preterm Birth
timeFrame: From 16-20 weeks gestation through preterm delivery
Secondary outcomes:
measure: Preterm Birth
timeFrame: From 16-20 weeks gestation through preterm delivery
measure: Gestational Age at Delivery
timeFrame: From 16-20 weeks gestation through preterm delivery
measure: Mean Neonatal Birth Weight
timeFrame: At delivery
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Andrew Elimian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.