Delivery DelayedNCT03025503
Nipple Stimulation for Labor Induction
A study testing nipple stimulation in people with Delivery Delayed, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This study will examine the use of nipple stimulation for cervical ripening in women who present to the labor and delivery ward after their water has broken but have a contraindication to prostaglandins. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery Delayed
- What is being tested?
- nipple stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to Jan 2019
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Week 37 + 0 and on
- PROM (premature rupture of membranes)
- Multiparity (birth sixth or higher) or TOLAC (trial of labor after Caesarean section)
- Not in active labor - without regular contractions fetal monitor, cervical dilation < 4 cm and effacement < 80%.
Who cannot join
- Water break > 24 hours at the time of admission to the delivery room
- Active vaginal bleeding with suspected placental abruption
- Maternal fever
- Multifetal pregnancy
- Women with contraindication for vaginal birth
- Preeclampsia
Show all 9Show fewer
- IUGR (intrauterine growth restriction)
- Macrosomia
- Non-reassuring fetal heart tracing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nipple Stimulation for Labor Induction: Efficiency, Safety and Satisfaction Measures
This study will examine the use of nipple stimulation for cervical ripening in women who present to the labor and delivery ward after their water has broken but have a contraindication to prostaglandins.
- Conditions
- Delivery Delayed
- Being tested
- nipple stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nipple stimulationOther
| Study group | Role | What they receive |
|---|---|---|
| nipple stimulation | Experimental | Not described Receives: Other: nipple stimulation |
| no intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression to active labor as measured by the Bishop score
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery DelayedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025503
- Sponsor's protocol ID
- NippleStim-HMO-CTIL
- Status last verified
- Dec 2016
- First submitted
- 18 Dec 2016
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nipple Stimulation for Labor Induction: Efficiency, Safety and Satisfaction Measures
- ClinicalTrials.gov ID
- NCT03025503
- Acronym / sponsor ID
- NippleStim-HMO-CTIL
- Conditions
- Delivery Delayed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 19 Jan 2017 (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 will examine the use of nipple stimulation for cervical ripening in women who present to the labor and delivery ward after their water has broken but have a contraindication to prostaglandins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nipple stimulation | Experimental | Other: nipple stimulation |
| no intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Week 37 + 0 and on
- PROM (premature rupture of membranes)
- Multiparity (birth sixth or higher) or TOLAC (trial of labor after Caesarean section)
- Not in active labor - without regular contractions fetal monitor, cervical dilation < 4 cm and effacement < 80%.
Key exclusion criteria (9 listed)
- Water break > 24 hours at the time of admission to the delivery room
- Active vaginal bleeding with suspected placental abruption
- Maternal fever
- Multifetal pregnancy
- Women with contraindication for vaginal birth
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 |
|---|---|---|
| nipple stimulation | Other | nipple stimulation |
Primary outcome
progression to active labor as measured by the Bishop score
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nipple stimulation in people with Delivery Delayed, run by Hadassah Medical Organization at 1 site in Israel.
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 4 inclusion and 9 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 19 Jan 2017. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Drorith Hochner-Celnikier, MD (00 972 2 5844400, hochner@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression to active labor as measured by the Bishop score (time frame: 6 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 19 Jan 2017.