Induced; Birth(REDUCED-I)NCT05037617
The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction
A study testing Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation). in people with Induced; Birth, run by University of Calgary at 1 site in Canada.
Trial summary
This pilot project is a randomized controlled trial where induced patients receive an intervention of oxytocin discontinuation once in the active stage of labor (≥6 cm dilation). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced; Birth
- What is being tested?
- Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 1 siteCanada
- Study dates
- 25 Oct 2021to 15 Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnant women undergoing induction of labor with oxytocin.
- Primiparous
- 18 years old or older
- at term (≥37 weeks)
- cephalic presenting
- singleton fetus
Who cannot join
- Multiple pregnancies
- known fetal congenital or chromosomal anomalies
Trial locations and contacts
1 site in 1 country.
About this study
This pilot project is a randomized controlled trial where induced patients receive an intervention of oxytocin discontinuation once in the active stage of labor (≥6 cm dilation). The intent is to reduce uterine hyperstimulation and fetal distress, therefore, lowering cesarean sections (CS) in first time mothers at term (≥ 37 weeks), with a cephalic presenting singleton fetus, without increasing maternal or neonatal morbidity. If REDUCE-I pilot trial suggests a safe reduction in CS rates and patient satisfaction, application for a multi-centre randomized controlled trial would follow.
Read the detailed description
This pilot project is a randomized controlled trial of a proposed intervention to modify management of labor inductions once in the active first stage of labor. The intervention will take place at Foothills Medical Centre (FMC). Randomization will be computer generated, participants will be stratified by need for cervical ripening and randomization will be blocked. Participants will be primiparous women 18 years old or older, at term (≥ 37 weeks) with a cephalic presenting singelton fetus undergoing induction of labor with oxytocin. Once patients are in the active first stage of labor, study medication will be initiated (identical vials of oxytocin or saline prepared by the Alberta Health Services Research Pharmacy). Treatment period will continue until delivery. If the frequency of contractions are reduced to less than 2 in 10 minutes or there has been no change in dilation for 4 hours, then oxytocin can be restarted.
Royal Alexandra Hospital in Edmonton will be used as a contemporaneous non-intervention control site.
- Conditions
- Induced; Birth
- Being tested
- Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).
- Keywords
- Obstetric Labor Complications, Cesarean section, Induced labour, oxytocin
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).Drug
Also called oxytocin
At the intervention site (Foothills Medical Centre), for participants who consent to being part of the trial, once a patient is found to be >= 6 cm dilation, the study medication will be initiated. Pharmacy will make up identical vials of oxytocin or saline, which will be numbered according to the random allocation sequence created by the study statistician.
The intervention will be continued until delivery unless contractions decrease to less than 2 in 10 minutes or if no further cervical dilation is noted 4 hours after discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention site (Foothills Medical Centre): Continuation of Oxytocin | Experimental | Participants in this arm will receive a blinded vial of oxytocin once a patient is found to be >= 6 cm dilated. Receives: Drug: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation). |
| Intervention site (Foothills Medical Centre): Discontinuation of oxytocin | Placebo comparator | Participants in this arm will receive a blinded vial of saline solution once a patient is found to be >= 6 cm dilated. Receives: Drug: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Cesarean section in labor
Rate of Cesarean section in labor
Measured: At Delivery
Occurrence of Uterine Hyperstimulation
Occurrence of >5 contractions in 10 minutes
Measured: During labour, after >=6 cm dilation
Proportion of screened subjects who agree to enroll in the trial
Proportion of screened subjects who agree to enroll in the trial
Measured: During screening of potential participants
Secondary outcomes (9)
Rate of perinatal death
Rate of perinatal death
Measured: At delivery
Rate of neonatal asphyxia
Neonatal asphyxia is defined as intrapartum stillbirth or neonatal death from asphyxia (Perinatal Society of Australia and New Zealand coding) or Neonatal Intensive Care Unit admission and at least two of: a. Apgar score of ≤5 at 10 minutes; b. Mechanical ventilation or chest compressions for resuscitation within 10 minutes; c. Cord pH < 7.00 (venous or arterial), or arterial base excess ≥ 12 at birth. Rate of neonatal asphyxia for deliveries involving primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus
Measured: At delivery
Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling
Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling
Measured: At delivery
Rate of neonatal sepsis or suspected sepsis
Rate of neonatal sepsis or suspected sepsis
Measured: At delivery
Rate of postpartum hemorrhage
Rate of postpartum hemorrhage
Measured: At delivery
Rate of blood transfusion
Rate of blood transfusion
Measured: At delivery
Rate of postpartum uterine artery/pelvic artery embolization
Rate of postpartum uterine artery/pelvic artery embolization
Measured: Within 28 days of delivery
Rate of postpartum hysterectomy
Rate of postpartum hysterectomy
Measured: Within 28 days of delivery
Rate of postpartum maternal intensive care unit (ICU) admission
Rate of postpartum maternal intensive care unit (ICU) admission
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start25 Oct 2021
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced; 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once a patient is found to be \>=6 cm dilation, the patient will received a blinded vial of oxytocin or saline, which will be numbered according to the random allocation sequence created by the study statistician.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Wood, University of Calgary
- Investigators
- Stephen L Wood, MD, FRCSC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037617
- Sponsor's protocol ID
- REB21-0614
- Acronym
- (REDUCED-I)
- Status last verified
- Mar 2024
- First submitted
- 19 Aug 2021
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction
- ClinicalTrials.gov ID
- NCT05037617
- Acronym / sponsor ID
- (REDUCED-I) / REB21-0614
- Conditions
- Induced; Birth
- Keywords
- Obstetric Labor Complications, Cesarean section, Induced labour, oxytocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 8 Sep 2021 (actual)
- 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.
This pilot project is a randomized controlled trial where induced patients receive an intervention of oxytocin discontinuation once in the active stage of labor (≥6 cm dilation). The intent is to reduce uterine hyperstimulation and fetal distress, therefore, lowering cesarean sections (CS) in first time mothers at term (≥ 37 weeks), with a cephalic presenting singleton fetus, without increasing maternal or neonatal morbidity. If REDUCE-I pilot trial suggests a safe reduction in CS rates and patient satisfaction, application for a multi-centre randomized controlled trial would follow.
Detailed description
This pilot project is a randomized controlled trial of a proposed intervention to modify management of labor inductions once in the active first stage of labor. The intervention will take place at Foothills Medical Centre (FMC). Randomization will be computer generated, participants will be stratified by need for cervical ripening and randomization will be blocked. Participants will be primiparous women 18 years old or older, at term (≥ 37 weeks) with a cephalic presenting singelton fetus undergoing induction of labor with oxytocin. Once patients are in the active first stage of labor, study medication will be initiated (identical vials of oxytocin or saline prepared by the Alberta Health Services Research Pharmacy). Treatment period will continue until delivery. If the frequency of contractions are reduced to less than 2 in 10 minutes or there has been no change in dilation for 4 hours, then oxytocin can be restarted.
Royal Alexandra Hospital in Edmonton will be used as a contemporaneous non-intervention control site.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Once a patient is found to be >=6 cm dilation, the patient will received a blinded vial of oxytocin or saline, which will be numbered according to the random allocation sequence created by the study statistician.
| Arm | Type | Receives |
|---|---|---|
| Intervention site (Foothills Medical Centre): Continuation of Oxytocin | Experimental | Drug: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).Participants in this arm will receive a blinded vial of oxytocin once a patient is found to be >= 6 cm dilated. |
| Intervention site (Foothills Medical Centre): Discontinuation of oxytocin | Placebo comparator | Drug: Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).Participants in this arm will receive a blinded vial of saline solution once a patient is found to be >= 6 cm dilated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pregnant women undergoing induction of labor with oxytocin.
- Primiparous
- 18 years old or older
- at term (≥37 weeks)
- cephalic presenting
Key exclusion criteria (2 listed)
- Multiple pregnancies
- known fetal congenital or chromosomal anomalies
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 |
|---|---|---|
| Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation).Also: oxytocinAt the intervention site (Foothills Medical Centre), for participants who consent to being part of the trial, once a patient is found to be >= 6 cm dilation, the study medication will be initiated. Pharmacy will make up identical vials of oxytocin or saline, which will be numbered according to the random allocation sequence created by the study statistician. The intervention will be continued until delivery unless contractions decrease to less than 2 in 10 minutes or if no further cervical dilation is noted 4 hours after discontinuation. | Drug | Intervention site (Foothills Medical Centre): Continuation of Oxytocin, Intervention site (Foothills Medical Centre): Discontinuation of oxytocin |
Primary outcome
Rate of Cesarean section in labor
Time frame: At Delivery
Rate of Cesarean section in labor
Occurrence of Uterine Hyperstimulation
Time frame: During labour, after >=6 cm dilation
Occurrence of >5 contractions in 10 minutes
Proportion of screened subjects who agree to enroll in the trial
Time frame: During screening of potential participants
Proportion of screened subjects who agree to enroll in the trial
9 secondary outcomes
Rate of perinatal death
Time frame: At delivery
Rate of neonatal asphyxia
Time frame: At delivery
Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling
Time frame: At delivery
Rate of neonatal sepsis or suspected sepsis
Time frame: At delivery
Rate of postpartum hemorrhage
Time frame: At delivery
Rate of blood transfusion
Time frame: At delivery
Rate of postpartum uterine artery/pelvic artery embolization
Time frame: Within 28 days of delivery
Rate of postpartum hysterectomy
Time frame: Within 28 days of delivery
Rate of postpartum maternal intensive care unit (ICU) admission
Time frame: At delivery
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 26 Mar 2024.
- 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.
Stephen L Wood, MD, FRCSC 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 study testing Continuation or discontinuation of oxytocin during the active first stage of labor (≥6 cm dilation). in people with Induced; 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 6 inclusion and 2 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 26 Mar 2024. 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?
Rate of Cesarean section in labor (time frame: At Delivery). The study lists 3 primary outcomes in all. 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 26 Mar 2024.