FindTrial
Sign In

Comparing IM vs. Vaginal Progesterone for Pre-term Birth

Comparing Intramuscular Versus Vaginal Progesterone for Prevention of Preterm Birth.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00579553
Enrollment
174
Registered
2007-12-24
Start date
2006-10-31
Completion date
2011-05-31
Last updated
2021-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Premature, Premature Birth

Keywords

Pre Term, Pre Term Birth, Premature Birth, Premature baby, High risk pregnancy, Progesterone, IM Progesterone, Vaginal Progesterone

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.

Interventions

DRUGIntramuscular Progesterone

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

DRUGVaginal Progesterone

Vaginal Progesterone: 100 mg vaginal suppository daily

Sponsors

University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Preterm BirthFrom 16-20 weeks gestation through preterm deliveryDelivery before 37 weeks gestation.

Secondary

MeasureTime frameDescription
Preterm BirthFrom 16-20 weeks gestation through preterm deliveryDelivery below 34 weeks gestation
Gestational Age at DeliveryFrom 16-20 weeks gestation through preterm deliveryMean gestational age at delivery
Mean Neonatal Birth WeightAt delivery—

Countries

United States

Participant flow

Participants by arm

ArmCount
Intramuscular Progesterone
Intramuscular Progesterone Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P
66
Vaginal Progesterone
Vaginal Progesterone Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily
79
Total145

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up1613

Baseline characteristics

CharacteristicIntramuscular ProgesteroneVaginal ProgesteroneTotal
Age, Continuous25.6 years
STANDARD_DEVIATION 4.3
26.8 years
STANDARD_DEVIATION 4.7
26.3 years
STANDARD_DEVIATION 4.5
Educational Level
College
6 Participants9 Participants15 Participants
Educational Level
High School
38 Participants44 Participants82 Participants
Educational Level
Less than high school
22 Participants26 Participants48 Participants
Region of Enrollment
United States
66 participants79 participants145 participants
Sex: Female, Male
Female
66 Participants79 Participants145 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Tobacco use
No tobacco use
55 Participants63 Participants118 Participants
Tobacco use
Tobacco use
11 Participants16 Participants27 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 660 / 79
other
Total, other adverse events
0 / 660 / 79
serious
Total, serious adverse events
0 / 660 / 79

Outcome results

Primary

Preterm Birth

Delivery before 37 weeks gestation.

Time frame: From 16-20 weeks gestation through preterm delivery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intramuscular ProgesteronePreterm Birth29 Participants
Vaginal ProgesteronePreterm Birth30 Participants
Secondary

Gestational Age at Delivery

Mean gestational age at delivery

Time frame: From 16-20 weeks gestation through preterm delivery

ArmMeasureValue (MEAN)Dispersion
Intramuscular ProgesteroneGestational Age at Delivery35.8 Weeks gestationStandard Deviation 4.7
Vaginal ProgesteroneGestational Age at Delivery36.3 Weeks gestationStandard Deviation 5.7
Secondary

Mean Neonatal Birth Weight

Time frame: At delivery

ArmMeasureValue (MEAN)Dispersion
Intramuscular ProgesteroneMean Neonatal Birth Weight2680.6 gramsStandard Deviation 840
Vaginal ProgesteroneMean Neonatal Birth Weight2771.6 gramsStandard Deviation 1131
Secondary

Preterm Birth

Delivery below 34 weeks gestation

Time frame: From 16-20 weeks gestation through preterm delivery

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intramuscular ProgesteronePreterm BirthDelivery less than 34 weeks13 Participants
Intramuscular ProgesteronePreterm BirthDelivery less than 28 weeks7 Participants
Vaginal ProgesteronePreterm BirthDelivery less than 34 weeks14 Participants
Vaginal ProgesteronePreterm BirthDelivery less than 28 weeks8 Participants

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026