Induction of LaborPhase 2NCT01916291
Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38
A Phase 2 study testing Propess insertion group in people with Induction of Labor, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has intact membrane after 38weeks of gestational age. The investigators study safety and efficacy of dinoprostone in the pregnant women with premature rupture of membrane or GA<38weeks Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Induction of Labor
- What is being tested?
- Propess insertion group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 25 Aug 2013to 4 Apr 2019
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women who admitted for induction of labor
- Bishop score <= 6
Who cannot join
- Contraindication to induction of labor
- Active labor
- Vaginal bleeding, unknown origin
- Hypersensitive to Prostaglandin E
- History of asthma, glaucoma
- Infection (birth canal)
Show all 13Show fewer
- Placental abruption
- Multiparity(>5)
- Pelvic inflammatory disease
- Heart, lung, kidney disease
- Multiple pregnancy
- Major anomaly
- Fetal distress before induction of labor
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Seoul, 110744
Seoul Metropolitan Goverment Seoul National University Boramae Medical Center
Seoul, 156707
About this study
Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has intact membrane after 38weeks of gestational age. The investigators study safety and efficacy of dinoprostone in the pregnant women with premature rupture of membrane or GA<38weeks
- Conditions
- Induction of Labor
- Being tested
- Propess insertion group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propess insertion groupDrug
| Study group | Role | What they receive |
|---|---|---|
| Propess insertion | Experimental | Not described Receives: Drug: Propess insertion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction success rate after propess insertion
Measured: Day 1 after propess insertion
Secondary outcomes (1)
Concentration of prostaglandinE
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 posted5 Aug 2013 (estimated)
- Study start25 Aug 2013
- Primary completion14 Aug 2018
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joong Shin Park, MD PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916291
- Sponsor's protocol ID
- Propess in PROM or GA<38
- Status last verified
- Sep 2018
- First submitted
- 29 Jul 2013
- Last updated
- 24 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38
- ClinicalTrials.gov ID
- NCT01916291
- Acronym / sponsor ID
- Propess in PROM or GA<38
- Conditions
- Induction of Labor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Aug 2013 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 5 Aug 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.
Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has intact membrane after 38weeks of gestational age. The investigators study safety and efficacy of dinoprostone in the pregnant women with premature rupture of membrane or GA<38weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propess insertion | Experimental | Drug: Propess insertion group |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women who admitted for induction of labor
- Bishop score <= 6
Key exclusion criteria (13 listed)
- Contraindication to induction of labor
- Active labor
- Vaginal bleeding, unknown origin
- Hypersensitive to Prostaglandin E
- History of asthma, glaucoma
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 |
|---|---|---|
| Propess insertion group | Drug | Propess insertion |
Primary outcome
Induction success rate after propess insertion
Time frame: Day 1 after propess insertion
1 secondary outcome
Concentration of prostaglandinE
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 24 Mar 2020.
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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.
Joong Shin Park, MD PhD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propess insertion group in people with Induction of Labor, run by Seoul National University Hospital at 2 sites 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 2 inclusion and 13 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 24 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 2 sites 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.
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 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?
Induction success rate after propess insertion (time frame: Day 1 after propess insertion). 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 24 Mar 2020.