Fetal Membranes, Premature RuptureNCT00259519
Safety and Efficacy Study of Intentional Delivery in Women With Preterm and Prelabour Rupture of the Membranes
A study testing Induction of delivery in people with Fetal Membranes, Premature Rupture, run by University of Alberta at 11 sites in Canada.
Trial summary
Two-year multicentre randomized controlled parallel trial to compare intentional delivery and conservative management in pregnant women with preterm and prelabour rupture of membranes between 32 and 35 weeks. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetal Membranes, Premature Rupture
- What is being tested?
- Induction of delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 11 sitesCanada
- Study dates
- Jan 2006to Mar 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with recent PPROM between 31 weeks + 6 days and 35 weeks + 6 days (estimated gestational age based on an ultrasound examination before 18 weeks of gestation), not in labour 24 hours after admission*, will be considered eligible for the study provided the following inclusion criteria (*For patients transferred from a remote level 2 centre to one of the participating sites within the first hours after PPROM, the onset of the 24-hour screening period will be the time of admission in the centre of origin. Patients in Group A will be given their first dose of antenatal steroids before the transfer)
- Single and otherwise uncomplicated pregnancy
- Recent history (less than 48 hours) of leaking with the two followings within 24 hours after primary medical assessment: Documentation of fluid from the vagina and Positive Fern test, or positive Nitrazine test, or Positive ACTIM PROM test
- Antenatal steroids course initiated after the rupture for women with PPROM between 31 + 6 and 33 + 6 weeks
- Normal fetal heart rate trace using an external ultrasound transducer
- Written informed consent obtained before inclusion and randomization
Who cannot join
- Multiple pregnancy
- HIV positive mother
- Active HSV cervical lesions
- Major fetal anomaly on ultrasound examination performed after admission
- Intrauterine growth restriction estimated on ultrasound below the 5th percentile or preeclampsia
- Placenta abruption present at the time of the diagnosis of PPROM or occurring within the first 24 hours after rupture
Show all 10Show fewer
- Clinical chorioamnionitis existing before or at the time of the diagnosis of PPROM or developing within the first 24 hours after rupture
- Non-reassuring fetal testing present at the time of the diagnosis of PPROM or occurring within the first 24 hours after the rupture. It implies that expected criteria for standard fetal assessment parameters have not been met, including the Non-Stress test and the Biophysical profile Score. This will be diagnosed at the discretion of the attending physician.
- More generally, any maternal or fetal reason for an immediate delivery, either existing at admission or occurring within the 24 hours after admission.
- Mother refusal or inability to provide consent
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
Foothills Hospital
Calgary, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, T5H3V9
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8
Caritas - Misericordia Hospital
Edmonton, Alberta, T6R 4H5
Saint-Joseph Health Care
London, Ontario, N6A 4V2
Sainte-Justine Hospital
Montreal, Quebec
Laval University Hospital
Québec, Quebec
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
BC Women's Hospital and Health Centre
Vancouver, British Columbia, V6H 3N1
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Women's Hospital
Winnipeg, Manitoba, R3L 0W8
About this study
Official title: Effects of Intentional Delivery After Preterm and Prelabor Rupture of Membranes Between 32 and 35 Weeks of Gestation: A Multicentre Randomized and Controlled Trial
Two-year multicentre randomized controlled parallel trial to compare intentional delivery and conservative management in pregnant women with preterm and prelabour rupture of membranes between 32 and 35 weeks.
The purpose of this study is to determine whether intentional delivery of women with PPROM between 32 and 35 week's gestation can decrease the overall neonatal morbidity associated with PPROM-related complications without increasing the morbidity associated with a shortened pregnancy.
- Conditions
- Fetal Membranes, Premature Rupture
- Being tested
- Induction of delivery
- Keywords
- premature or preterm birth, chorioamnionitis, neonatal sepsis, labour, Cesarean Section, delivery, length of stay, pregnancy
- Medical subject headings
- Fetal Membranes, Premature Rupture, Premature Birth, Chorioamnionitis, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of deliveryProcedure or surgery
Also called immediate delivery
Induction of delivery
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Expectant management |
| 2 | Active comparator | Induction of delivery Receives: Procedure: Induction of delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay in hospital
Measured: time between birth and readiness for discharge
Secondary outcomes (5)
MAIN Score (Morbidity Assessment Index for Newborns)
Measured: From birth to discharge
Early Onset Neonatal Sepsis
Measured: from birth to discharge
Clinical and Histological Chorioamnionitis
Measured: from birth to discharge
Antepartum Length of stay
Measured: From diagnosis to delivery
C-Section
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startJan 2006
- Primary completionMar 2010
- Study completionMar 2020
Why it stopped: The DSMB supported termination of the trial due to slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Membranes, Premature RuptureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Stollery Children's Hospital Foundation
- Responsible party
- Sponsor
- Investigators
- Thierry Lacaze-Masmonteil, MD, PhD, Principal investigator, University of AlbertaRadha Chari, MD,FRCPC, Principal investigator, University of Alberta- Department of Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259519
- Sponsor's protocol ID
- N041000314
- Status last verified
- Mar 2020
- First submitted
- 25 Nov 2005
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intentional Delivery After Preterm and Prelabor Rupture of Membranes Between 32 and 35 Weeks of Gestation: A Multicentre Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT00259519
- Acronym / sponsor ID
- N041000314
- Conditions
- Fetal Membranes, Premature Rupture
- Keywords
- premature or preterm birth, chorioamnionitis, neonatal sepsis, labour, Cesarean Section, delivery, length of stay, pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The DSMB supported termination of the trial due to slow recruitment.
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Stollery Children's Hospital Foundation
- Study start
- Jan 2006 (actual)
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 29 Nov 2005 (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.
Two-year multicentre randomized controlled parallel trial to compare intentional delivery and conservative management in pregnant women with preterm and prelabour rupture of membranes between 32 and 35 weeks.
The purpose of this study is to determine whether intentional delivery of women with PPROM between 32 and 35 week's gestation can decrease the overall neonatal morbidity associated with PPROM-related complications without increasing the morbidity associated with a shortened pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Expectant management |
| 2 | Active comparator | Procedure: Induction of deliveryInduction of delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Women with recent PPROM between 31 weeks + 6 days and 35 weeks + 6 days (estimated gestational age based on an ultrasound examination before 18 weeks of gestation), not in labour 24 hours after admission*, will be considered eligible for the study provided the following inclusion criteria (*For patients transferred from a remote level 2 centre to one of the participating sites within the first hours after PPROM, the onset of the 24-hour screening period will be the time of admission in the centre of origin. Patients in Group A will be given their first dose of antenatal steroids before the transfer)
- Single and otherwise uncomplicated pregnancy
- Recent history (less than 48 hours) of leaking with the two followings within 24 hours after primary medical assessment: Documentation of fluid from the vagina and Positive Fern test, or positive Nitrazine test, or Positive ACTIM PROM test
- Antenatal steroids course initiated after the rupture for women with PPROM between 31 + 6 and 33 + 6 weeks
- Normal fetal heart rate trace using an external ultrasound transducer
Key exclusion criteria (10 listed)
- Multiple pregnancy
- HIV positive mother
- Active HSV cervical lesions
- Major fetal anomaly on ultrasound examination performed after admission
- Intrauterine growth restriction estimated on ultrasound below the 5th percentile or preeclampsia
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 |
|---|---|---|
| Induction of deliveryAlso: immediate deliveryInduction of delivery | Procedure or surgery | 2 |
Primary outcome
Length of Stay in hospital
Time frame: time between birth and readiness for discharge
5 secondary outcomes
MAIN Score (Morbidity Assessment Index for Newborns)
Time frame: From birth to discharge
Early Onset Neonatal Sepsis
Time frame: from birth to discharge
Clinical and Histological Chorioamnionitis
Time frame: from birth to discharge
Antepartum Length of stay
Time frame: From diagnosis to delivery
C-Section
Time frame: delivery
Results and safety
The study was stopped early (reason given: The DSMB supported termination of the trial due to slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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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.
Thierry Lacaze-Masmonteil, MD, PhD principal investigator
University of Alberta
Radha Chari, MD,FRCPC principal investigator
University of Alberta- Department of Gynecology and Obstetrics
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction of delivery in people with Fetal Membranes, Premature Rupture, run by University of Alberta at 11 sites 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 6 inclusion and 10 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 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. 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 was stopped early (reason given: The DSMB supported termination of the trial due to slow recruitment.). 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?
Length of Stay in hospital (time frame: time between birth and readiness for discharge). 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 25 Mar 2020.