Failed Induction of LaborNCT02618096
Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Multiparous Women at Term
A study testing Oxytocin, Dinoprostone and Membrane sweeping in people with Failed Induction of Labor, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for multiparas at term with an unfavorable cervix. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Failed Induction of Labor
- What is being tested?
- Oxytocin, Dinoprostone and Membrane sweeping
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Oct 2018
- 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
- singleton pregnancy
- Multiparous women
- gestational age >=37.0 weeks
- Bishop score <=6
- intact amniotic membrane
- absence of labor
- live fetus with vertex presentation
- no previous uterine surgical procedure
Who cannot join
- Multiple pregnancy
- Placenta previa
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
The purpose of this study is to compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for multiparas at term with an unfavorable cervix.
- Conditions
- Failed Induction of Labor
- Being tested
- Oxytocin, Dinoprostone, Membrane sweeping
- Keywords
- membrane sweeping, dinoprostone, multiparas, labor induction, cesarean delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
DinoprostoneDrug
Membrane sweepingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin & Membrane sweeping | Active comparator | Women assigned to "Concurrent oxytocin with membrane sweeping" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, followed by oxytocin infusion the next day Receives: Drug: Oxytocin; Procedure: Membrane sweeping |
| Oxytocin & Dinoprostone | Active comparator | Women assigned to "Concurrent oxytocin with dinoprostone vaginal insert": The 10mg dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening, followed by oxytocin infusion the next day Receives: Drug: Oxytocin; Drug: Dinoprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal delivery within 24 hours
Vaginal delivery within 24 hours is defined as vaginal delivery after 24 hours of initiating intervention (i.e. membrane sweeping or dinoprostone) on the first day of induction.
Measured: From the time of initiating intervention (i.e. membrane sweeping or dinoprostone) until the time of vaginal delivery, assessed up to 24 hours
Secondary outcomes (3)
Successful labor induction
to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm
Measured: From the time of initiating intervention (i.e. membrane sweeping or dinoprostone) until the time of active phase of labor (defined as a cervical dilatation of >=4cm), assessed up to 24 hours
Incidence of cesarean delivery
Measured: End of labor induction (assessed up to 120 hours)
The interval from start of oxytocin to delivery
Measured: From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Induction of LaborStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyo Hoon Park,, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618096
- Sponsor's protocol ID
- SWP_PG_M2
- Status last verified
- Oct 2016
- First submitted
- 25 Sep 2015
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Multiparous Women at Term
- ClinicalTrials.gov ID
- NCT02618096
- Acronym / sponsor ID
- SWP_PG_M2
- Conditions
- Failed Induction of Labor
- Keywords
- membrane sweeping, dinoprostone, multiparas, labor induction, cesarean delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 1 Dec 2015 (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 compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for multiparas at term with an unfavorable cervix.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin & Membrane sweeping | Active comparator | Drug: Oxytocin, Procedure: Membrane sweepingWomen assigned to "Concurrent oxytocin with membrane sweeping" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, followed by oxytocin infusion the next day |
| Oxytocin & Dinoprostone | Active comparator | Drug: Oxytocin, Drug: DinoprostoneWomen assigned to "Concurrent oxytocin with dinoprostone vaginal insert": The 10mg dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening, followed by oxytocin infusion the next day |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- singleton pregnancy
- Multiparous women
- gestational age >=37.0 weeks
- Bishop score <=6
- intact amniotic membrane
Key exclusion criteria (2 listed)
- Multiple pregnancy
- Placenta previa
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 | Oxytocin & Dinoprostone, Oxytocin & Membrane sweeping |
| Dinoprostone | Drug | Oxytocin & Dinoprostone |
| Membrane sweeping | Procedure or surgery | Oxytocin & Membrane sweeping |
Primary outcome
Vaginal delivery within 24 hours
Time frame: From the time of initiating intervention (i.e. membrane sweeping or dinoprostone) until the time of vaginal delivery, assessed up to 24 hours
Vaginal delivery within 24 hours is defined as vaginal delivery after 24 hours of initiating intervention (i.e. membrane sweeping or dinoprostone) on the first day of induction.
3 secondary outcomes
Successful labor induction
Time frame: From the time of initiating intervention (i.e. membrane sweeping or dinoprostone) until the time of active phase of labor (defined as a cervical dilatation of >=4cm), assessed up to 24 hours
Incidence of cesarean delivery
Time frame: End of labor induction (assessed up to 120 hours)
The interval from start of oxytocin to delivery
Time frame: From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours
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 4 Mar 2020.
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.
Kyo Hoon Park,, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin, Dinoprostone and Membrane sweeping in people with Failed Induction of Labor, run by Seoul National University Hospital at 1 site in South Korea.
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 8 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 4 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 1 site in South Korea. 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 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?
Vaginal delivery within 24 hours (time frame: From the time of initiating intervention (i.e. membrane sweeping or dinoprostone) until the time of vaginal delivery, assessed up to 24 hours). 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 4 Mar 2020.