Nulliparous Women Who Scheduled for Labor InductionNCT01792375
Concurrent Membrane Sweeping With Dinoprostone Versus Dinoprostone in Labor Induction of Nulliparas at Term With an Unfavorable Cervix
A study testing Concurrent membrane sweeping with Dinoprostone and 10mg Dinoprostone vaginal insert in people with Nulliparous Women Who Scheduled for Labor Induction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To compare concurrent membrane sweeping with dinoprostone versus dinoprostone in labor induction for nulliparas at term with an unfavorable cervix Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Nulliparous Women Who Scheduled for Labor Induction
- What is being tested?
- Concurrent membrane sweeping with Dinoprostone and 10mg Dinoprostone vaginal insert
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Feb 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
- Nulliparous 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
To compare concurrent membrane sweeping with dinoprostone versus dinoprostone in labor induction for nulliparas at term with an unfavorable cervix
- Being tested
- Concurrent membrane sweeping with Dinoprostone, 10mg Dinoprostone vaginal insert
- Keywords
- Cervical ripening, Dinoprostone, Labor induction, Membrane sweeping, Nulliparous women, Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent membrane sweeping with DinoprostoneProcedure or surgery
Women assigned to "Sweep" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, immediately followed by the placement of a 10mg Dinoprostone vaginal insert in the posterior fornix.
10mg Dinoprostone vaginal insertDrug
For women assigned to "No sweep": The only 10mg Dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening
| Study group | Role | What they receive |
|---|---|---|
| Concurrent membrane sweeping with Dinoprostone | Active comparator | Not described Receives: Procedure: Concurrent membrane sweeping with Dinoprostone |
| Dinoprostone | Active comparator | Not described Receives: Drug: 10mg Dinoprostone vaginal insert |
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. concurrent membrane sweeping with dinoprostone or only dinoprostone) on the first day of induction.
Measured: Twenty-four hours of initiating intervention (i.e. membrane sweeping or PG) on the first day of induction
Secondary outcomes (1)
Cervical change in the bishop scores and cervical lengths
- Cervical change based on the bishop score and cervical length induced by two cervical ripening methods(concurrent membrane sweeping with dinoprostone vs. dinoprostone)
- Incidence of cesarean delivery
- Successful labor induction (defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm).
- The interval from start of oxytocin to delivery
- Incidence of rupture of membranes
- Incidences of vaginal bleeding and fever
Measured: Initiation of oxytocin after removing dinoprostone vaginal insert
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nulliparous Women Who Scheduled for Labor InductionStudies 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
- 192 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 Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792375
- Sponsor's protocol ID
- SWP_PG_Null
- Status last verified
- Oct 2016
- First submitted
- 13 Feb 2013
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
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 Membrane Sweeping With Dinoprostone Versus Dinoprostone in Labor Induction of Nulliparas at Term With an Unfavorable Cervix
- ClinicalTrials.gov ID
- NCT01792375
- Acronym / sponsor ID
- SWP_PG_Null
- Keywords
- Cervical ripening, Dinoprostone, Labor induction, Membrane sweeping, Nulliparous women, Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 15 Feb 2013 (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.
To compare concurrent membrane sweeping with dinoprostone versus dinoprostone in labor induction for nulliparas 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 |
|---|---|---|
| Concurrent membrane sweeping with Dinoprostone | Active comparator | Procedure: Concurrent membrane sweeping with Dinoprostone |
| Dinoprostone | Active comparator | Drug: 10mg Dinoprostone vaginal insert |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- singleton pregnancy
- Nulliparous 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 |
|---|---|---|
| Concurrent membrane sweeping with DinoprostoneWomen assigned to "Sweep" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, immediately followed by the placement of a 10mg Dinoprostone vaginal insert in the posterior fornix. | Procedure or surgery | Concurrent membrane sweeping with Dinoprostone |
| 10mg Dinoprostone vaginal insertFor women assigned to "No sweep": The only 10mg Dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening | Drug | Dinoprostone |
Primary outcome
Vaginal delivery within 24 hours
Time frame: Twenty-four hours of initiating intervention (i.e. membrane sweeping or PG) on the first day of induction
Vaginal delivery within 24 hours is defined as vaginal delivery after 24 hours of initiating intervention (i.e. concurrent membrane sweeping with dinoprostone or only dinoprostone) on the first day of induction.
1 secondary outcome
Cervical change in the bishop scores and cervical lengths
Time frame: Initiation of oxytocin after removing dinoprostone vaginal insert
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.
Related trials for Nulliparous Women Who Scheduled for Labor Induction
Recruiting
Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
Nulliparous Women Who Scheduled for Labor Induction, Pregnancy
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 Bundang 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 Concurrent membrane sweeping with Dinoprostone and 10mg Dinoprostone vaginal insert in people with Nulliparous Women Who Scheduled for Labor Induction, 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: Twenty-four hours of initiating intervention (i.e. membrane sweeping or PG) on the first day of induction). 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.