Preterm BirthNCT00343265
Vaginal Progesterone Versus Placebo in Multiple Pregnancy
A study testing Vaginal progesterone gel in people with Preterm Birth, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this study is to see if daily use of vaginal progesterone will prevent preterm birth in women carrying 2 or more babies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Vaginal progesterone gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2006to Mar 2011
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed multiple pregnancy
- Ultrasound confirmed minimum of 2 live fetuses
- Gestational age 16-20 6/7 weeks
Who cannot join
- Placenta previa
- Pre-existing hypertension
- Major fetal anomaly
- Monoamniotic, monozygotic multiples
- Maternal seizure disorder
- History of, or active, thromboembolic disease
Show all 12Show fewer
- Maternal live disease
- Breast malignancy or pathology
- Progesterone dependent neoplasia
- Plans to move to another city during pregnancy
- Sensitivity to progesterone
- Participation in other clinical trials during the pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomized Trial of Vaginal Progesterone to Prevent Preterm Birth in Multiple Pregnancy
The purpose of this study is to see if daily use of vaginal progesterone will prevent preterm birth in women carrying 2 or more babies.
Read the detailed description
Women who are pregnant with twins or any higher order multiple will be approached to take part. Women will be randomized to get either vaginal progesterone gel or a placebo gel daily from study entry until 35 6/7 weeks. Women can enter the study between 16 - 20 6/7 weeks. Two hundred women will be recruited to take part. Data will be collected on the women and their infants to see if the active medication prolongs pregnancy.
- Conditions
- Preterm Birth
- Being tested
- Vaginal progesterone gel, Placebo gel
- Keywords
- Preterm birth, Multiple pregnancy, Vaginal progesterone, Preterm birth in multiple pregnancy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal progesterone gelDrug
Vaginal gel once daily
Placebo gelDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Progesterone gel Receives: Drug: Vaginal progesterone gel |
| 2 | Placebo comparator | Vaginal gel with no medication Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age
Measured: Delivery
Secondary outcomes (8)
Proportion of women delivering < 35 weeks
Measured: Delivery
Proportion of women delivering < 37 weeks
Measured: Delivery
Proportion of women having spontaneous preterm delivery
Measured: Delivery
Proportion of women having tocolytic therapy
Measured: During pregnancy
Treatment compliance
Measured: Delivery
Length of stay for mother and infants
Measured: Discharge
Infant morbidity and mortality
Measured: Discharge
Birth weight
Measured: Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Calgary Health Region, Juniper Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Dr. Sue Ross, University of Calgary
- Investigators
- Stephen Wood, MD, Principal investigator, University of CalgarySue Ross, PhD, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343265
- Sponsor's protocol ID
- 18589
- Other IDs
- 9427-U0206-47C, 104425
- Status last verified
- Aug 2013
- First submitted
- 20 Jun 2006
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wood S, Ross S, Tang S, Miller L, Sauve R, Brant R. Vaginal progesterone to prevent preterm birth in multiple pregnancy: a randomized controlled trial. J Perinat Med. 2012 Nov;40(6):593-9. doi: 10.1515/jpm-2012-0057.
PubMed 23093256
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of Vaginal Progesterone to Prevent Preterm Birth in Multiple Pregnancy
- ClinicalTrials.gov ID
- NCT00343265
- Acronym / sponsor ID
- 18589
- Conditions
- Preterm Birth
- Keywords
- Preterm birth, Multiple pregnancy, Vaginal progesterone, Preterm birth in multiple pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Calgary Health Region, Juniper Pharmaceuticals, Inc.
- Study start
- Jun 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Jun 2006 (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.
The purpose of this study is to see if daily use of vaginal progesterone will prevent preterm birth in women carrying 2 or more babies.
Detailed description
Women who are pregnant with twins or any higher order multiple will be approached to take part. Women will be randomized to get either vaginal progesterone gel or a placebo gel daily from study entry until 35 6/7 weeks. Women can enter the study between 16 - 20 6/7 weeks. Two hundred women will be recruited to take part. Data will be collected on the women and their infants to see if the active medication prolongs pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Vaginal progesterone gelProgesterone gel |
| 2 | Placebo comparator | Drug: Placebo gelVaginal gel with no medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed multiple pregnancy
- Ultrasound confirmed minimum of 2 live fetuses
- Gestational age 16-20 6/7 weeks
Key exclusion criteria (12 listed)
- Placenta previa
- Pre-existing hypertension
- Major fetal anomaly
- Monoamniotic, monozygotic multiples
- Maternal seizure disorder
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 progesterone gelVaginal gel once daily | Drug | 1 |
| Placebo gelonce daily | Drug | 2 |
Primary outcome
Gestational age
Time frame: Delivery
8 secondary outcomes
Proportion of women delivering < 35 weeks
Time frame: Delivery
Proportion of women delivering < 37 weeks
Time frame: Delivery
Proportion of women having spontaneous preterm delivery
Time frame: Delivery
Proportion of women having tocolytic therapy
Time frame: During pregnancy
Treatment compliance
Time frame: Delivery
Length of stay for mother and infants
Time frame: Discharge
Infant morbidity and mortality
Time frame: Discharge
Birth weight
Time frame: Birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
- Results publication: PubMed 23093256Wood S, Ross S, Tang S, Miller L, Sauve R, Brant R. Vaginal progesterone to prevent preterm birth in multiple pregnancy: a randomized controlled trial. J Perinat Med. 2012 Nov;40(6):593-9. doi: 10.1515/jpm-2012-0057.
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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 principal investigator
University of Calgary
Sue Ross, PhD study director
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 study testing Vaginal progesterone gel in people with Preterm Birth, 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 3 inclusion and 12 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 15 Aug 2013. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 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 NCT00343265, 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 15 Aug 2013.