Infant, PrematureNCT00579553
Comparing IM vs. Vaginal Progesterone for Pre-term Birth
A study testing Intramuscular Progesterone and Vaginal Progesterone in people with Infant, Premature and Premature Birth, run by University of Oklahoma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature, Premature Birth
- What is being tested?
- Intramuscular Progesterone and Vaginal Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Comparing Intramuscular Versus Vaginal Progesterone for Prevention of Preterm Birth.
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.
Read the 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
- Being tested
- Intramuscular Progesterone, Vaginal Progesterone
- Keywords
- Pre Term, Pre Term Birth, Premature Birth, Premature baby, High risk pregnancy, Progesterone, IM Progesterone, Vaginal Progesterone
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular ProgesteroneDrug
Also called 17 alpha hydroxyprogesterone caproate
Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P
Vaginal ProgesteroneDrug
Vaginal Progesterone: 100 mg vaginal suppository daily
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular Progesterone | Active comparator | Intramuscular Progesterone Receives: Drug: Intramuscular Progesterone |
| Vaginal Progesterone | Experimental | Vaginal Progesterone Receives: Drug: Vaginal Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm Birth
Delivery before 37 weeks gestation.
Measured: From 16-20 weeks gestation through preterm delivery
Secondary outcomes (3)
Preterm Birth
Delivery below 34 weeks gestation
Measured: From 16-20 weeks gestation through preterm delivery
Gestational Age at Delivery
Mean gestational age at delivery
Measured: From 16-20 weeks gestation through preterm delivery
Mean Neonatal Birth Weight
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startOct 2006
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Elimian, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579553
- Sponsor's protocol ID
- Progesterone75,643
- Status last verified
- Apr 2021
- First submitted
- 18 Dec 2007
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27168167
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Intramuscular Versus Vaginal Progesterone for Prevention of Preterm Birth.
- ClinicalTrials.gov ID
- NCT00579553
- Acronym / sponsor ID
- Progesterone75,643
- Conditions
- Infant, Premature, Premature Birth
- Keywords
- Pre Term, Pre Term Birth, Premature Birth, Premature baby, High risk pregnancy, Progesterone, IM Progesterone, Vaginal Progesterone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Posted 19 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramuscular Progesterone | Active comparator | Drug: Intramuscular ProgesteroneIntramuscular Progesterone |
| Vaginal Progesterone | Experimental | Drug: Vaginal ProgesteroneVaginal Progesterone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramuscular ProgesteroneAlso: 17 alpha hydroxyprogesterone caproateIntramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P | Drug | Intramuscular Progesterone |
| Vaginal ProgesteroneVaginal Progesterone: 100 mg vaginal suppository daily | Drug | Vaginal Progesterone |
Primary outcome
Preterm Birth
Time frame: From 16-20 weeks gestation through preterm delivery
Delivery before 37 weeks gestation.
3 secondary outcomes
Preterm Birth
Time frame: From 16-20 weeks gestation through preterm delivery
Gestational Age at Delivery
Time frame: From 16-20 weeks gestation through preterm delivery
Mean Neonatal Birth Weight
Time frame: At delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27168167Elimian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Elimian, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramuscular Progesterone and Vaginal Progesterone in people with Infant, Premature and Premature Birth, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm Birth (time frame: From 16-20 weeks gestation through preterm delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00579553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.