Pregnancy ComplicationsPhase 2/3NCT00946088
Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial
A Phase 2/3 study testing Progesterone and Polyethylene glycol&hydrogenated vegetable oil. in people with Pregnancy Complications, run by Stanford University at 1 site in United States.
Trial summary
Preterm delivery is the most common cause of infant morbidity and mortality in the United States. Some women have episodes of preterm labor during their pregnancy which can be temporarily stopped. These women, however, are at high risk for delivering before term. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Progesterone and Polyethylene glycol&hydrogenated vegetable oil.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2015
- Phase
- Phase 2/3
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Inclusion Criteria:1. Pregnant women with arrested preterm labor between 24+0 to 33+6 weeks pregnant.
- Intact membranes 3. Singleton pregnancy 4. Greater than or equal to 18 years of age 5. Cervical dilation less than or equal to 4cm Exclusion Criteria:1. Any contraindication to on-going pregnancy 2. Placental abruption 3. Placenta previa 4. Lethal fetal anomalies 5. Premature rupture of membranes 6. Multiple gestation 7. Less than 18 years old 8. Known allergy to any component of the study medication or placebo 9. Severe maternal medical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Preterm delivery is the most common cause of infant morbidity and mortality in the United States. Some women have episodes of preterm labor during their pregnancy which can be temporarily stopped. These women, however, are at high risk for delivering before term. At this time, we do not have sufficient evidence to use any medication to help prevent these women from delivering early. Recently, preliminary studies have shown that progesterone may help prevent some women at high risk for preterm delivery from delivering early. Our study will investigate whether progesterone can help this specific group of women, women with arrested preterm labor, deliver healthy infants at term.
Read the detailed description
The purpose of this study is to test the efficacy of progesterone in prolonging human pregnancies complicated by arrested preterm labor. Animal labor has not been shown to be equivalent to human labor and would not be an appropriate substitute for this study.
In addition, this medication has been previously used in pregnant women without any evidence of significant harm to the mother or fetus. Women will be approached for enrollment in the study during their hospitalization for preterm labor. If they choose to enroll, they will have weekly MD visits at the obstetrical clinic, daily use of vaginal progesterone that will be self administered, and routine obstetric care at the time of recurrent labor and delivery. The daily progesterone is not a part of routine care for these patients. In addition, we will ask patients to fill out a written questionaire one week after starting the medication to describe any subjective symptoms that may be associated with this medication. Finally, we will assess the peripheral levels of progesterone with a blood draw prior to starting the mediation, one week after starting the medication, and at the time of recurrent pre-term labor or delivery. The first two of these blood draws will be in addition to the standard treatment. The final blood draw will involve collecting an extra sample at a time when the participant would normally have blood drawn as a part of routine care.
- Conditions
- Pregnancy Complications
- Being tested
- Progesterone, Polyethylene glycol&hydrogenated vegetable oil.
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Progesterone 400 mg per vagina qhs.
Polyethylene glycol&hydrogenated vegetable oil.Drug
Placebo Comparator: Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina qhs.
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Active comparator | Progesterone 400mg per vagina qhs. Receives: Drug: Progesterone |
| Polyethylene glycol&hydrogenated vegetable oil | Placebo comparator | Polyethylene glycol\&hydrogenated vegetable oil per vagina Receives: Drug: Polyethylene glycol&hydrogenated vegetable oil. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Delivery Rate Prior to 37 Weeks Gestation
Reduction in delivery rate prior to 37 weeks gestation (preterm birth).
Measured: Up to 37 weeks of gestation
Secondary outcomes (8)
Maternal Chorioamnionitis
Measured: Up to maternal hospital discharge
Maternal Anticipated Adverse Medication Reaction
Measured: Up to the maternal discharge from delivery hospitalization
Birthweight
Newborn birthweight in grams
Measured: At the time of newborn birth
Neonatal Intensive Care Unit (NICU) Admission
Measured: At time of neonatal discharge
Neonatal Morbidity
Measured: Up to 28 days after neonatal birth
Neonatal Mortality
Measured: Up to 28 days after neonatal birth
Neonatal Congenital Abnormalities
Measured: Up to the time of neonatal discharge from the delivery hospital
Number of Days Delay of Delivery
Number of days from intervention to delivery
Measured: Up to the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2013
- Study completionMar 2015
Why it stopped: lower than expected enrollment
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 Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deirdre Judith Lyell, Stanford University
- Investigators
- Deirdre Judith Lyell, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946088
- Sponsor's protocol ID
- SU-03312009-2078
- Other IDs
- 11625
- Status last verified
- Feb 2017
- First submitted
- 22 Jul 2009
- Last updated
- 16 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00946088
- Acronym / sponsor ID
- SU-03312009-2078
- Conditions
- Pregnancy Complications
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lower than expected enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Posted 8 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm delivery is the most common cause of infant morbidity and mortality in the United States. Some women have episodes of preterm labor during their pregnancy which can be temporarily stopped. These women, however, are at high risk for delivering before term. At this time, we do not have sufficient evidence to use any medication to help prevent these women from delivering early. Recently, preliminary studies have shown that progesterone may help prevent some women at high risk for preterm delivery from delivering early. Our study will investigate whether progesterone can help this specific group of women, women with arrested preterm labor, deliver healthy infants at term.
Detailed description
The purpose of this study is to test the efficacy of progesterone in prolonging human pregnancies complicated by arrested preterm labor. Animal labor has not been shown to be equivalent to human labor and would not be an appropriate substitute for this study.
In addition, this medication has been previously used in pregnant women without any evidence of significant harm to the mother or fetus. Women will be approached for enrollment in the study during their hospitalization for preterm labor. If they choose to enroll, they will have weekly MD visits at the obstetrical clinic, daily use of vaginal progesterone that will be self administered, and routine obstetric care at the time of recurrent labor and delivery. The daily progesterone is not a part of routine care for these patients. In addition, we will ask patients to fill out a written questionaire one week after starting the medication to describe any subjective symptoms that may be associated with this medication. Finally, we will assess the peripheral levels of progesterone with a blood draw prior to starting the mediation, one week after starting the medication, and at the time of recurrent pre-term labor or delivery. The first two of these blood draws will be in addition to the standard treatment. The final blood draw will involve collecting an extra sample at a time when the participant would normally have blood drawn as a part of routine care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Active comparator | Drug: ProgesteroneProgesterone 400mg per vagina qhs. |
| Polyethylene glycol&hydrogenated vegetable oil | Placebo comparator | Drug: Polyethylene glycol&hydrogenated vegetable oil.Polyethylene glycol\&hydrogenated vegetable oil per vagina |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| ProgesteroneProgesterone 400 mg per vagina qhs. | Drug | Progesterone |
| Polyethylene glycol&hydrogenated vegetable oil.Placebo Comparator: Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina qhs. | Drug | Polyethylene glycol&hydrogenated vegetable oil |
Primary outcome
Reduction in Delivery Rate Prior to 37 Weeks Gestation
Time frame: Up to 37 weeks of gestation
Reduction in delivery rate prior to 37 weeks gestation (preterm birth).
8 secondary outcomes
Maternal Chorioamnionitis
Time frame: Up to maternal hospital discharge
Maternal Anticipated Adverse Medication Reaction
Time frame: Up to the maternal discharge from delivery hospitalization
Birthweight
Time frame: At the time of newborn birth
Neonatal Intensive Care Unit (NICU) Admission
Time frame: At time of neonatal discharge
Neonatal Morbidity
Time frame: Up to 28 days after neonatal birth
Neonatal Mortality
Time frame: Up to 28 days after neonatal birth
Neonatal Congenital Abnormalities
Time frame: Up to the time of neonatal discharge from the delivery hospital
Number of Days Delay of Delivery
Time frame: Up to the time of delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Deirdre Judith Lyell, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Progesterone and Polyethylene glycol&hydrogenated vegetable oil. in people with Pregnancy Complications, run by Stanford University 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?
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: stopped early, as of the sponsor's last update on 16 Mar 2017. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 8 Feb 2017). 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?
Reduction in Delivery Rate Prior to 37 Weeks Gestation (time frame: Up to 37 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2017.