Pregnancy ComplicationsPhase 1/2NCT01050647
Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
A Phase 1/2 study testing 17-Hydroxyprogesterone Caproate and Caster Oil injections in people with Pregnancy Complications, run by Stanford University at 2 sites in United States.
Trial summary
Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- 17-Hydroxyprogesterone Caproate and Caster Oil injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2010to Dec 2015
- Phase
- Phase 1/2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 18yr of age
- Singleton pregnancy
- PPROM confirmed on clinical exam
- GA between 24+0 and 33+5 wk
- Ability to understand consent in either English or Spanish
Who cannot join
- Contraindication to ongoing pregnancy including:
- Evidence of active infection
- Evidence of significant placental abruption
- IUFD diagnosed at the time of P-PROM diagnosis
- Major fetal malformation
- Maternal allergy to progesterone or placebo drug components
Show all 9Show fewer
- Current use of progesterone at the time of P-PROM
- Multiple Gestations
- Inability to understand consent in either English or Spanish
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Santa Clara Valley Medical Center
San Jose, California, 95128
Stanford University School of Medicine
Stanford, California, 94305
About this study
Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. Specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (PPROM).
Read the detailed description
When women present to either the Obstetrical clinic or labor and delivery with a complaint of possible preterm, premature rupture of membranes (PPROM), they will be examined by an obstetrician to either confirm or rule out this diagnosis. If they are diagnosed with PPROM, they will then be admitted to Lucile Packard Children's Hospital and treated with the normal protocol which includes receiving antibiotics, receiving steroids, being hospitalized until delivery, and having ongoing maternal and fetal monitoring for possible complications. The patients will be identified by their treating obstetricians as possible study candidates and asked by a member of the treatment team if they are potentially interested in participating in a research study. Subsequently, a member of the study team or the treating physician will approach the patient about participating in the trial. Those who choose to participate will receive the standard care protocol in addition to receiving the study medication. The study medication will be a weekly injection of either placebo or 17-hydroxyprogesterone caproate or placebo. The placebo medication (castor oil) was chosen as it has been used in previous studies as a placebo for 17-hydroxyprogesterone caproate. The choice of which medication the patient receives will be determined by a randomization table. Only the pharmacist will be aware of the medication that has been administered. The patient, members of the treatment team, and members of the study team will be blinded to the medication that is being administered. The timing of their delivery will be managed by the treating obstetrician according to standard medical practice. After delivery, the patient's and her infant's medical outcomes will be recorded for analysis.
- Conditions
- Pregnancy Complications
- Being tested
- 17-Hydroxyprogesterone Caproate, Caster Oil injections
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-Hydroxyprogesterone CaproateDrug
Also called Active study drug
Weekly injections of 17-hydroxyprogesterone caproate.
Caster Oil injectionsOther
Also called Placebo
Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.
| Study group | Role | What they receive |
|---|---|---|
| 17-hydroxyprogesterone caproate | Active comparator | Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation Receives: Drug: 17-Hydroxyprogesterone Caproate |
| Castor oil injections | Placebo comparator | Weekly injections of Caster Oil (placebo) Receives: Other: Caster Oil injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Achievement of 34 Weeks Gestation
Delayed delivery until 34 weeks gestation.
Measured: From enrollment until delivery, an average of 34 weeks
Secondary outcomes (5)
Number of Participants With Neonatal Respiratory Distress Syndrome
Measured: From delivery until neonatal hospital discharge, assessed up to 2 months
Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage
Measured: From delivery until neonatal hospital discharge, assessed up to 2 months
Number of Participants With Neonatal Necrotizing Enterocolitis
Measured: From delivery to neonatal discharge, assessed up to 2 months
Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days
Measured: From birth to discharge form delivery hospital, assessed up to 2 months
Length of Latency Assessed as Number of Days
Measured: From rupture of membranes until delivery, assessed up to 34 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2015
- Study completionDec 2015
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Yehia El-Sayed, Stanford University
- Investigators
- Yasser Y El-Sayed, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050647
- Sponsor's protocol ID
- SU-01082010-4683
- Other IDs
- 17976
- Status last verified
- Apr 2019
- First submitted
- 13 Jan 2010
- Last updated
- 9 Apr 2019
- 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 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01050647
- Acronym / sponsor ID
- SU-01082010-4683
- Conditions
- Pregnancy Complications
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Posted 17 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. Specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (PPROM).
Detailed description
When women present to either the Obstetrical clinic or labor and delivery with a complaint of possible preterm, premature rupture of membranes (PPROM), they will be examined by an obstetrician to either confirm or rule out this diagnosis. If they are diagnosed with PPROM, they will then be admitted to Lucile Packard Children's Hospital and treated with the normal protocol which includes receiving antibiotics, receiving steroids, being hospitalized until delivery, and having ongoing maternal and fetal monitoring for possible complications. The patients will be identified by their treating obstetricians as possible study candidates and asked by a member of the treatment team if they are potentially interested in participating in a research study. Subsequently, a member of the study team or the treating physician will approach the patient about participating in the trial. Those who choose to participate will receive the standard care protocol in addition to receiving the study medication. The study medication will be a weekly injection of either placebo or 17-hydroxyprogesterone caproate or placebo. The placebo medication (castor oil) was chosen as it has been used in previous studies as a placebo for 17-hydroxyprogesterone caproate. The choice of which medication the patient receives will be determined by a randomization table. Only the pharmacist will be aware of the medication that has been administered. The patient, members of the treatment team, and members of the study team will be blinded to the medication that is being administered. The timing of their delivery will be managed by the treating obstetrician according to standard medical practice. After delivery, the patient's and her infant's medical outcomes will be recorded for analysis.
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 |
|---|---|---|
| 17-hydroxyprogesterone caproate | Active comparator | Drug: 17-Hydroxyprogesterone CaproateWeekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation |
| Castor oil injections | Placebo comparator | Other: Caster Oil injectionsWeekly injections of Caster Oil (placebo) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 18yr of age
- Singleton pregnancy
- PPROM confirmed on clinical exam
- GA between 24+0 and 33+5 wk
- Ability to understand consent in either English or Spanish
Key exclusion criteria (9 listed)
- Contraindication to ongoing pregnancy including:
- Major fetal malformation
- Maternal allergy to progesterone or placebo drug components
- Current use of progesterone at the time of P-PROM
- Multiple Gestations
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 |
|---|---|---|
| 17-Hydroxyprogesterone CaproateAlso: Active study drugWeekly injections of 17-hydroxyprogesterone caproate. | Drug | 17-hydroxyprogesterone caproate |
| Caster Oil injectionsAlso: PlaceboWeekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation. | Other | Castor oil injections |
Primary outcome
Number of Participants With Achievement of 34 Weeks Gestation
Time frame: From enrollment until delivery, an average of 34 weeks
Delayed delivery until 34 weeks gestation.
5 secondary outcomes
Number of Participants With Neonatal Respiratory Distress Syndrome
Time frame: From delivery until neonatal hospital discharge, assessed up to 2 months
Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage
Time frame: From delivery until neonatal hospital discharge, assessed up to 2 months
Number of Participants With Neonatal Necrotizing Enterocolitis
Time frame: From delivery to neonatal discharge, assessed up to 2 months
Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days
Time frame: From birth to discharge form delivery hospital, assessed up to 2 months
Length of Latency Assessed as Number of Days
Time frame: From rupture of membranes until delivery, assessed up to 34 weeks of gestation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- 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.
Yasser Y El-Sayed, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 17-Hydroxyprogesterone Caproate and Caster Oil injections in people with Pregnancy Complications, run by Stanford University at 2 sites 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 5 inclusion and 9 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 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 17 Apr 2018). 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?
Number of Participants With Achievement of 34 Weeks Gestation (time frame: From enrollment until delivery, an average of 34 weeks). 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 9 Apr 2019.