Fetal Membranes, Premature RupturePhase 2IC-PROMNCT00890630
Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term
A Phase 2 study testing Intracervical Balloon Catheter and Oxytocin in people with Fetal Membranes, Premature Rupture and Induced Labor, run by McMaster University at 1 site in Canada.
Trial summary
The purpose of this study is to examine the feasibility of using intracervical balloon catheters for cervical ripening as part of labour induction in healthy, GBS-negative women with prelabour rupture of membranes at term. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetal Membranes, Premature Rupture, Induced Labor
- What is being tested?
- Intracervical Balloon Catheter and Oxytocin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Jul 2011
- Phase
- Phase 2
- 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
- Singleton Pregnancy
- 37.0 and 41.0 gestational age
- Confirmed Rupture of Membranes
- Group B Streptococcus Negative
- Cephalic Presentation
- Absence of contractions for at least 60 minutes following rupture
- Absence of contractions at time of enrolment
Who cannot join
- Contraindication to Vaginal Delivery
- Previous Uterine Surgery, including Caesarean Section
- Previous Cerclage, Cone Biopsy, LEEP, or Cervical Surgery
- Documented history of cervical incompetence
- High Grade intraepithelial lesion, adenocarcinoma in situ, or invasive cervical cancer.
- Immunosuppressed State
- Active Vaginal Infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term: A Pilot Study.
The purpose of this study is to examine the feasibility of using intracervical balloon catheters for cervical ripening as part of labour induction in healthy, GBS-negative women with prelabour rupture of membranes at term.
Read the detailed description
This is a randomized controlled trial comparing two methods of induction of labour for pregnant, GBS-negative women presenting with prelabour rupture of membranes at term.
The intervention consists of the insertion of a double-balloon intracervical catheter at the time of induction, followed immediately by oxytocin infusion. The control consists of standard therapy: oxytocin induction. Our primary outcome is feasibility, and our secondary outcomes are length of first and second stages of labour, rate of vaginal delivery, intrapartum fever, chorioamnionitis, NICU admission, suspected or proven neonatal sepsis, or serious neonatal complication.
- Conditions
- Fetal Membranes, Premature Rupture, Induced Labor
- Being tested
- Intracervical Balloon Catheter, Oxytocin
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracervical Balloon CatheterProcedure or surgery
Intracervical insertion of an 80cc Double-Balloon Catheter.
OxytocinDrug
IV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | Induction of Labour with Oxytocin Alone Receives: Drug: Oxytocin |
| Intracervical Catheter | Experimental | Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction. Receives: Procedure: Intracervical Balloon Catheter; Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Measured: 48 hours
Secondary outcomes (5)
Intrapartum Fever
Measured: 48 Hours
Duration of Labour
Measured: 48 hours
NICU Admission
Measured: 0-7 days postpartum
Chorioamnionitis
Measured: 48 Hours
Patient Satisfaction
Measured: 0-6 weeks Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Inadequate Patient Recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fetal Membranes, Premature RuptureStudies of the same condition, open and under way.
- More trials run by McMaster 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Investigators
- Dustin Costescu, MD, BSc, Principal investigator, McMaster University, Department of Obstetrics and GynaecologyAmie Cullimore, MD BSc BEd, Principal investigator, McMaster University, Department of Obstetrics and Gynaecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890630
- Sponsor's protocol ID
- 09-3265
- Acronym
- IC-PROM
- Status last verified
- Jul 2011
- First submitted
- 27 Apr 2009
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264Costescu DJ, Cullimore AJ. Lessons learned from a resident-led clinical trial in obstetrics. Clin Trials. 2013 Aug;10(4):612-6. doi: 10.1177/1740774513492045. Epub 2013 Jun 13.
PubMed 23766376
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term: A Pilot Study.
- ClinicalTrials.gov ID
- NCT00890630
- Acronym / sponsor ID
- IC-PROM / 09-3265
- Conditions
- Fetal Membranes, Premature Rupture, Induced Labor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate Patient Recruitment.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 30 Apr 2009 (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 examine the feasibility of using intracervical balloon catheters for cervical ripening as part of labour induction in healthy, GBS-negative women with prelabour rupture of membranes at term.
Detailed description
This is a randomized controlled trial comparing two methods of induction of labour for pregnant, GBS-negative women presenting with prelabour rupture of membranes at term.
The intervention consists of the insertion of a double-balloon intracervical catheter at the time of induction, followed immediately by oxytocin infusion. The control consists of standard therapy: oxytocin induction. Our primary outcome is feasibility, and our secondary outcomes are length of first and second stages of labour, rate of vaginal delivery, intrapartum fever, chorioamnionitis, NICU admission, suspected or proven neonatal sepsis, or serious neonatal complication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: OxytocinInduction of Labour with Oxytocin Alone |
| Intracervical Catheter | Experimental | Procedure: Intracervical Balloon Catheter, Drug: OxytocinInsertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Singleton Pregnancy
- 37.0 and 41.0 gestational age
- Confirmed Rupture of Membranes
- Group B Streptococcus Negative
- Cephalic Presentation
Key exclusion criteria (7 listed)
- Contraindication to Vaginal Delivery
- Previous Uterine Surgery, including Caesarean Section
- Previous Cerclage, Cone Biopsy, LEEP, or Cervical Surgery
- Documented history of cervical incompetence
- High Grade intraepithelial lesion, adenocarcinoma in situ, or invasive cervical cancer.
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 |
|---|---|---|
| Intracervical Balloon CatheterIntracervical insertion of an 80cc Double-Balloon Catheter. | Procedure or surgery | Intracervical Catheter |
| OxytocinIV Oxytocin infusion, dose dependent on patient response. Start at 2mIU/min, increasing every 30 minutes by 2mIU/min, to max 24mIU/min. | Drug | Intracervical Catheter, Oxytocin |
Primary outcome
Feasibility
Time frame: 48 hours
5 secondary outcomes
Intrapartum Fever
Time frame: 48 Hours
Duration of Labour
Time frame: 48 hours
NICU Admission
Time frame: 0-7 days postpartum
Chorioamnionitis
Time frame: 48 Hours
Patient Satisfaction
Time frame: 0-6 weeks Postpartum
Results and safety
The study was stopped early (reason given: Inadequate Patient Recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Derived from this study: PubMed 23766376Costescu DJ, Cullimore AJ. Lessons learned from a resident-led clinical trial in obstetrics. Clin Trials. 2013 Aug;10(4):612-6. doi: 10.1177/1740774513492045. Epub 2013 Jun 13.
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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.
Dustin Costescu, MD, BSc principal investigator
McMaster University, Department of Obstetrics and Gynaecology
Amie Cullimore, MD BSc BEd principal investigator
McMaster University, Department of Obstetrics and Gynaecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intracervical Balloon Catheter and Oxytocin in people with Fetal Membranes, Premature Rupture and Induced Labor, run by McMaster University 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 7 inclusion and 7 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 20 Jul 2011. 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. 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 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?
The study was stopped early (reason given: Inadequate Patient 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?
Feasibility (time frame: 48 hours). 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 NCT00890630, which also lists 2 linked publications.
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 20 Jul 2011.