Obstetric Labor, PrematurePhase 4PROTONCT01286246
Randomized Controlled Trial of Vaginal Progesterone in Women With Threatened Preterm Labor
A Phase 4 study testing Vaginal progesterone in people with Obstetric Labor, Premature, run by University of Calgary at 1 site in Canada.
Trial summary
Prematurity remains the most important single factor in perinatal morbidity and mortality. Unfortunately, the rate of premature delivery is increasing in Canada and is especially high in Alberta with 7.5% of pregnancies ending before 37 weeks gestation. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obstetric Labor, Premature
- What is being tested?
- Vaginal progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with symptomatic premature contractions successfully arrested for at least 12 hours with tocolytics.
- Women with symptoms suggestive of early preterm labor whose contractions resolve without tocolysis but are fetal fibronectin positive.
- Gestational age 23(+0)-32(+6) weeks.
- Consent to taking part in the study.
Who cannot join
- Placenta previa
- Preterm premature rupture of membranes at presentation
- Pre-existing hypertension will be excluded in order to reduce the likelihood of iatrogenic preterm delivery within the study women
- Known major fetal anomaly detected on ultrasound
- Multiple pregnancy
- Maternal seizure disorder
Show all 13Show fewer
- Active or history of thromboembolic disease
- Maternal liver disease
- Known or suspected breast malignancy or pathology
- Known or suspected progesterone-dependent neoplasia
- Plans to move to another city during pregnancy
- Previous participation in a progesterone trial during this pregnancy
- Known sensitivity to progesterone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomized Controlled Trial of Vaginal Progesterone to Prevent Preterm Birth in Women With Threatened Preterm Labor
Prematurity remains the most important single factor in perinatal morbidity and mortality. Unfortunately, the rate of premature delivery is increasing in Canada and is especially high in Alberta with 7.5% of pregnancies ending before 37 weeks gestation. Despite years of research into the causes of spontaneous preterm labor, few effective treatments have been identified. Progesterone is one candidate treatment. The purpose of this study is to investigate whether progesterone can prolong pregnancy in women who have symptoms of preterm labor.
Pregnant women who have symptoms of premature labor will be invited to take part in the study if they are between 22 to 24 weeks pregnant. If they agree to join the study, they will be randomly allocated to either take progesterone 200mg each day via the vagina until 36 weeks, or to take a placebo preparation. Neither the women nor their clinician will know which group they are in.
Read more
Women and their babies will be followed until 28 days after the birth, to find out about the length of the pregnancy, any adverse events that might occur (none have been reported in previous trials), and to look at whether women have taken the treatment.
When the study is complete, the results for the progesterone group will be compared to the placebo group. If progesterone is found to be useful in helping to prolong pregnancy, then this will be a possible treatment to help mothers in the future.
- Conditions
- Obstetric Labor, Premature
- Being tested
- Vaginal progesterone, Placebo
- Keywords
- Progesterone, Randomized controlled trial
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal progesteroneDrug
Also called Utrogestan
Capsules of 200mg micronised progesterone suspended in sunflower oil. One capsule inserted vaginally per day from time of randomisation to gestational age 35(+6)weeks or delivery (if sooner).
PlaceboDrug
Capsules of placebo (sunflower oil). One capsule inserted vaginally per day from time of randomisation to gestational age 35(+6)weeks or delivery (if sooner).
| Study group | Role | What they receive |
|---|---|---|
| Vaginal progesterone | Experimental | Not described Receives: Drug: Vaginal progesterone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at birth
Gestational age at birth calculated from gestational age at pre-randomization baseline
Measured: At birth
Secondary outcomes (12)
Proportion of women who have preterm birth <35 weeks
Measured: At birth
Proportion of women who have a preterm birth at <37 weeks
Measured: At birth
Maternal hospital length of stay (days)
Measured: Days from date of admission to date of discharge
Proportion of women who have hospital admission for premature labor
Measured: After birth
Maternal compliance with treatment
Diary self-report of treatment use
Measured: At time of birth
Neonatal hospital length of stay (days)
Measured: Days from birth to discharge from hospital
Neonatal morbidity
Respiratory distress syndrome (type 1), intraventricular hemorrhage, chronic lung disease, periventricular leukomalacia,necrotising eneterocolitis, retinopathy of prematurity
Measured: Up to 28 days after birth
Number of days of assisted ventilation (neonate)
Measured: Up to 28 days after birth
Number of days of supplemental oxygen (for neonate)
Measured: Up to 28 days after birth
Birth weight (grams)
Measured: At time of birth
Neonatal survival to discharge home (yes/no)
Measured: During 28 days after birth
Adverse events (maternal or neonate)
Measured: Up to 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Trial investigators were unable to recruit the estimated sample
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Labor, PrematureStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sue Ross, University of Calgary
- Investigators
- Stephen Wood, MD, MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286246
- Sponsor's protocol ID
- 21492
- Acronym
- PROTO
- Status last verified
- Jan 2015
- First submitted
- 27 Jan 2011
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of Vaginal Progesterone to Prevent Preterm Birth in Women With Threatened Preterm Labor
- ClinicalTrials.gov ID
- NCT01286246
- Acronym / sponsor ID
- PROTO / 21492
- Conditions
- Obstetric Labor, Premature
- Keywords
- Progesterone, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial investigators were unable to recruit the estimated sample
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prematurity remains the most important single factor in perinatal morbidity and mortality. Unfortunately, the rate of premature delivery is increasing in Canada and is especially high in Alberta with 7.5% of pregnancies ending before 37 weeks gestation. Despite years of research into the causes of spontaneous preterm labor, few effective treatments have been identified. Progesterone is one candidate treatment. The purpose of this study is to investigate whether progesterone can prolong pregnancy in women who have symptoms of preterm labor.
Pregnant women who have symptoms of premature labor will be invited to take part in the study if they are between 22 to 24 weeks pregnant. If they agree to join the study, they will be randomly allocated to either take progesterone 200mg each day via the vagina until 36 weeks, or to take a placebo preparation. Neither the women nor their clinician will know which group they are in.
Women and their babies will be followed until 28 days after the birth, to find out about the length of the pregnancy, any adverse events that might occur (none have been reported in previous trials), and to look at whether women have taken the treatment.
When the study is complete, the results for the progesterone group will be compared to the placebo group. If progesterone is found to be useful in helping to prolong pregnancy, then this will be a possible treatment to help mothers in the future.
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 |
|---|---|---|
| Vaginal progesterone | Experimental | Drug: Vaginal progesterone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with symptomatic premature contractions successfully arrested for at least 12 hours with tocolytics.
- Women with symptoms suggestive of early preterm labor whose contractions resolve without tocolysis but are fetal fibronectin positive.
- Gestational age 23(+0)-32(+6) weeks.
- Consent to taking part in the study.
Key exclusion criteria (13 listed)
- Placenta previa
- Preterm premature rupture of membranes at presentation
- Pre-existing hypertension will be excluded in order to reduce the likelihood of iatrogenic preterm delivery within the study women
- Known major fetal anomaly detected on ultrasound
- Multiple 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 |
|---|---|---|
| Vaginal progesteroneAlso: UtrogestanCapsules of 200mg micronised progesterone suspended in sunflower oil. One capsule inserted vaginally per day from time of randomisation to gestational age 35(+6)weeks or delivery (if sooner). | Drug | Vaginal progesterone |
| PlaceboCapsules of placebo (sunflower oil). One capsule inserted vaginally per day from time of randomisation to gestational age 35(+6)weeks or delivery (if sooner). | Drug | Placebo |
Primary outcome
Gestational age at birth
Time frame: At birth
Gestational age at birth calculated from gestational age at pre-randomization baseline
12 secondary outcomes
Proportion of women who have preterm birth <35 weeks
Time frame: At birth
Proportion of women who have a preterm birth at <37 weeks
Time frame: At birth
Maternal hospital length of stay (days)
Time frame: Days from date of admission to date of discharge
Proportion of women who have hospital admission for premature labor
Time frame: After birth
Maternal compliance with treatment
Time frame: At time of birth
Neonatal hospital length of stay (days)
Time frame: Days from birth to discharge from hospital
Neonatal morbidity
Time frame: Up to 28 days after birth
Number of days of assisted ventilation (neonate)
Time frame: Up to 28 days after birth
Number of days of supplemental oxygen (for neonate)
Time frame: Up to 28 days after birth
Birth weight (grams)
Time frame: At time of birth
Neonatal survival to discharge home (yes/no)
Time frame: During 28 days after birth
Adverse events (maternal or neonate)
Time frame: Up to 28 days after birth
Results and safety
The study was stopped early (reason given: Trial investigators were unable to recruit the estimated sample). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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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.
Stephen Wood, MD, MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaginal progesterone in people with Obstetric Labor, Premature, run by University of Calgary at 1 site in Canada.
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 13 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: stopped early, as of the sponsor's last update on 8 Jan 2015. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Trial investigators were unable to recruit the estimated sample). Results are not available in the source record.
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?
Gestational age at birth (time frame: At birth). 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 8 Jan 2015.