Preterm BirthPhase 3NCT01180296

Oral Progesterone for Prevention of Preterm Birth

A Phase 3 study testing oral micronized progesterone in people with Preterm Birth, run by Fetal Medicine Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate whether daily oral micronized progesterone is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels. Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Preterm Birth
What is being tested?: oral micronized progesterone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteUnited States
Study dates: Nov 2006to Jan 2009
Phase: Phase 3
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
No healthy volunteers
Adult

Who may be able to join

pregnant women less than 20 weeks' gestation who had at least one prior spontaneous preterm birth of a liveborn baby between 20 \& 0/7 weeks' and 36 \& 6/7 weeks' gestation.

Who cannot join

multiple gestations, the presence of major fetal anomalies, progesterone use in the current pregnancy (ongoing or past), the presence of a cervical cerclage, and the presence of a placenta previa.

Trial locations and contacts

1 site in 1 country.

United States1 site

Miami Valley HospitaL
Dayton, Ohio, 45409

Other trials in United States

About this study

Official title: Prevention of Recurrent Preterm Birth With Micronized Progesterone

Read the detailed description

To evaluate whether 400 mg daily oral micronized progesterone from 16 to 34 weeks' is effective in preventing recurrent spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal serum progesterone levels.

Conditions: Preterm Birth
Being tested: oral micronized progesterone, Identical Placebo tablet
Keywords: Preterm birth, prevention, progesterone, oral
Medical subject headings: Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oral micronized progesteroneDrug
Also called Prometrium(TM)
oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks
Identical Placebo tabletDrug
Also called Placebo
Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks

Study groups in NCT01180296
Study group	Role	What they receive
Progesterone Group	Experimental	Oral Micronized Progesterone Receives: Drug: oral micronized progesterone
Placebo	Placebo comparator	Identical Placebo Tablet Receives: Drug: Identical Placebo tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Recurrent Preterm Birth
Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.
Measured: Prior to 37 weeks' gestation

Secondary outcomes (1)

Secondary Outcomes
Serum progesterone levels
Measured: Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Jan 2009

First posted12 Aug 2010 (estimated)
Study startNov 2006
Primary completionJan 2009
Study completionJan 2009

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.
Other trials for Preterm BirthStudies of the same condition, open and under way.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01180296
Sponsor's protocol ID: MVH-MP-Pilot-RCT
Status last verified: Feb 2019
First submitted: 10 Aug 2010
Last updated: 18 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Preterm Birth trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Recurrent Preterm Birth With Micronized Progesterone
ClinicalTrials.gov ID: NCT01180296
Acronym / sponsor ID: MVH-MP-Pilot-RCT
Conditions: Preterm Birth
Keywords: Preterm birth, prevention, progesterone, oral
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Fetal Medicine FoundationUniversity, hospital or other
Study start: Nov 2006
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 12 Aug 2010 (estimated)
Results: Posted 21 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Progesterone Group	Experimental	Drug: oral micronized progesteroneOral Micronized Progesterone
Placebo	Placebo comparator	Drug: Identical Placebo tabletIdentical Placebo Tablet

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

pregnant women less than 20 weeks' gestation who had at least one prior spontaneous preterm birth of a liveborn baby between 20 \& 0/7 weeks' and 36 \& 6/7 weeks' gestation.

Key exclusion criteria (1 listed)

multiple gestations, the presence of major fetal anomalies, progesterone use in the current pregnancy (ongoing or past), the presence of a cervical cerclage, and the presence of a placenta previa.

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
oral micronized progesteroneAlso: Prometrium(TM)oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks	Drug	Progesterone Group
Identical Placebo tabletAlso: PlaceboIdentical Placebo tablet = placebo taking nightly from 16 to 34 weeks	Drug	Placebo

Primary outcome

Rate of Recurrent Preterm Birth
Time frame: Prior to 37 weeks' gestation
Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.

1 secondary outcome

Secondary Outcomes
Time frame: Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group

Results and safety

Results posted to the registry on 21 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Progesterone Group	20	19
Placebo	16	14

Primary outcome: Rate of Recurrent Preterm Birth

Time frame: Prior to 37 weeks' gestation. Number. Unit: participants

Measure	Progesterone Group n = 19	Placebo n = 14
Value	5	8

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From trial entry until delivery of the infant, average (+/- std dev) gestational age at randomization was 18.2 +/- 2.7 weeks for placebo group and 16.9 +/- 2.6 weeks for progesterone group; Average gestational age at delivery was 35.9 +/- 3.8 weeks for placebo group, and 37.0 +/- 2.7 weeks for progesterone group. The average duration adverse events were collected was 17.7 weeks for the placebo group, and 20.1 weeks for the progesterone group.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Progesterone Group	0 of 20 (0%)	0 of 20 (0%)	Not reported
Placebo	0 of 16 (0%)	0 of 16 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Preterm Birth

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
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Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
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Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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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.

David S McKenna, MD principal investigator

Fetal Medicine Foundation/USA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing oral micronized progesterone in people with Preterm Birth, run by Fetal Medicine Foundation 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 1 inclusion and 1 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 18 Feb 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2011). 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?

Rate of Recurrent Preterm Birth (time frame: Prior to 37 weeks' gestation). 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 NCT01180296.

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 18 Feb 2019.