Intemittant, Continue, OxytocinPhase 2NCT02859571
Continuous Versus Intermittent Oxytocin for Induction of Labor: A Randomized Study
A Phase 2 study testing Oxytocin in people with Intemittant, Continue, Oxytocin, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates continuous oxytocin versus intermittent oxytocin for induction of labor at term. Half of participants will be taken continuous oxytocin, while the other half will be taken intermittent oxytocin. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intemittant, Continue, Oxytocin
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2016to Jan 2017
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy,
- 37≤ weeks of gestational age ,
- vertex presentation,
- women with cervical dilation 3 cm
- no contraindication to vaginal delivery.
Who cannot join
- fetal malpresentation,
- multifetal pregnancy,
- more than three contractions in 10 minutes,
- contraindications to oxytocin,
- a category II or III fetal heart rate pattern,
- fetal anomaly,
- fetal demise
- women with immediate delivery indications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology
Istanbul, 34000
ahmet eser, medical doctor, +905056179623, drahmeteser@gmail.com
About this study
This study evaluates continuous oxytocin versus intermittent oxytocin for induction of labor at term. Half of participants will be taken continuous oxytocin, while the other half will be taken intermittent oxytocin.
Read the detailed description
In the continuous oxytocin group, traditional treatment of oxytocin used at a starting dose of 1-2 mIU/min and the dose was increased by 2 mIU/min at every 15 minutes until regular contractions obtained at a rate of 3-5 contractions in a 10-minute period. The maximum dose of oxytocin was 40 mIU/min and oxytocin was administered until delivery. In the intermittent group, oxytocin was discontinued when cervical dilation was 5 cm and 2 hours after discontinuation oxytocin was reused at a starting dose of 1-2 mIU/min and was increased as the same protocol used for continuation oxytocin group.
- Conditions
- Intemittant, Continue, Oxytocin
- Being tested
- Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
| Study group | Role | What they receive |
|---|---|---|
| Continuous oxytocin | Active comparator | oxytocin will be used at a starting dose of 1-2 mIU/min and the dose will be increased by 2 mIU/min at every 15 minutes until regular contractions will be obtained at a rate of 3-5 contractions in a 10-minute period. The maximum dose of oxytocin will 40 mIU/min and oxytocin will be administered until delivery. Receives: Drug: Oxytocin |
| intermittent oxytocin | Experimental | oxytocin will be discontinued when cervical dilation will 5 cm and 2 hours after discontinuation oxytocin will be reused at a starting dose of 1-2 mIU/min and will be increased as the same protocol will be used for continuation oxytocin group. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction-to-delivery time
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionJan 2017 (estimated)
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 Intemittant, Continue, OxytocinStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- evrim bostanci ergen, Principal investigator, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859571
- Sponsor's protocol ID
- 152
- Status last verified
- Dec 2016
- First submitted
- 4 Aug 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Bor P, Ledertoug S, Boie S, Knoblauch NO, Stornes I. Continuation versus discontinuation of oxytocin infusion during the active phase of labour: a randomised controlled trial. BJOG. 2016 Jan;123(1):129-35. doi: 10.1111/1471-0528.13589. Epub 2015 Aug 26.
PubMed 26309128Ozturk FH, Yilmaz SS, Yalvac S, Kandemir O. Effect of oxytocin discontinuation during the active phase of labor. J Matern Fetal Neonatal Med. 2015 Jan;28(2):196-8. doi: 10.3109/14767058.2014.906573. Epub 2014 Apr 9.
PubMed 24646336
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Intermittent Oxytocin for Induction of Labor: A Randomized Study
- ClinicalTrials.gov ID
- NCT02859571
- Acronym / sponsor ID
- 152
- Conditions
- Intemittant, Continue, Oxytocin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (estimated)
- First posted
- 9 Aug 2016 (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.
This study evaluates continuous oxytocin versus intermittent oxytocin for induction of labor at term. Half of participants will be taken continuous oxytocin, while the other half will be taken intermittent oxytocin.
Detailed description
In the continuous oxytocin group, traditional treatment of oxytocin used at a starting dose of 1-2 mIU/min and the dose was increased by 2 mIU/min at every 15 minutes until regular contractions obtained at a rate of 3-5 contractions in a 10-minute period. The maximum dose of oxytocin was 40 mIU/min and oxytocin was administered until delivery. In the intermittent group, oxytocin was discontinued when cervical dilation was 5 cm and 2 hours after discontinuation oxytocin was reused at a starting dose of 1-2 mIU/min and was increased as the same protocol used for continuation oxytocin group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous oxytocin | Active comparator | Drug: Oxytocinoxytocin will be used at a starting dose of 1-2 mIU/min and the dose will be increased by 2 mIU/min at every 15 minutes until regular contractions will be obtained at a rate of 3-5 contractions in a 10-minute period. The maximum dose of oxytocin will 40 mIU/min and oxytocin will be administered until delivery. |
| intermittent oxytocin | Experimental | Drug: Oxytocinoxytocin will be discontinued when cervical dilation will 5 cm and 2 hours after discontinuation oxytocin will be reused at a starting dose of 1-2 mIU/min and will be increased as the same protocol will be used for continuation oxytocin group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- singleton pregnancy,
- 37≤ weeks of gestational age ,
- vertex presentation,
- women with cervical dilation 3 cm
- no contraindication to vaginal delivery.
Key exclusion criteria (8 listed)
- fetal malpresentation,
- multifetal pregnancy,
- more than three contractions in 10 minutes,
- contraindications to oxytocin,
- a category II or III fetal heart rate pattern,
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 |
|---|---|---|
| Oxytocin | Drug | Continuous oxytocin, intermittent oxytocin |
Primary outcome
induction-to-delivery time
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Background: PubMed 26309128Bor P, Ledertoug S, Boie S, Knoblauch NO, Stornes I. Continuation versus discontinuation of oxytocin infusion during the active phase of labour: a randomised controlled trial. BJOG. 2016 Jan;123(1):129-35. doi: 10.1111/1471-0528.13589. Epub 2015 Aug 26.
- Background: PubMed 24646336Ozturk FH, Yilmaz SS, Yalvac S, Kandemir O. Effect of oxytocin discontinuation during the active phase of labor. J Matern Fetal Neonatal Med. 2015 Jan;28(2):196-8. doi: 10.3109/14767058.2014.906573. Epub 2014 Apr 9.
- Individual participant dataSharing planned: Yes
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.
evrim bostanci ergen principal investigator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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 Oxytocin in people with Intemittant, Continue, Oxytocin, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Dec 2016. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact evrim bostanci ergen, M.D. (505 617 96 23, evrimbostanc6666@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
induction-to-delivery time (time frame: intraoperative). 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 NCT02859571, 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 8 Dec 2016.