Labor, Induced"PRIME"NCT01641601
Prehospital Cervical Ripening Before Induction and the Maternal Experience
A study testing Outpatient transcervical Foley balloon in people with Labor, Induced and Cervical Ripening, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a randomized study evaluating the impact of pre-hospital cervical ripening with a transcervical Foley balloon before labor induction in full-term pregnancies on the length of inpatient labor induction and maternal satisfaction with the labor induction process. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Labor, Induced, Cervical Ripening
- What is being tested?
- Outpatient transcervical Foley balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Intrauterine pregnancy
- Cephalic presentation
- Greater than 36 weeks estimated gestational age
- Reassuring fetal status
- Normal amniotic fluid index
- Clinical indication for induction of labor
Who cannot join
- Prior cesarean section
- Bishop score on cervical examination ≥ 6
- Unreliable transportation
- Home > 30 minutes from the hospital
- Non-reassuring fetal status
- Abnormal amniotic fluid index
- Other indication for immediate hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Benioff Children's Hospital
San Francisco, California, 94143
About this study
Official title: Randomized Controlled Trial of Prehospital Cervical Ripening With an Outpatient Transcervical Foley Balloon and the Duration of Induction and Maternal Satisfaction
This is a randomized study evaluating the impact of pre-hospital cervical ripening with a transcervical Foley balloon before labor induction in full-term pregnancies on the length of inpatient labor induction and maternal satisfaction with the labor induction process. The investigators hypothesize that women who receive pre-hospital cervical ripening will have a shorter duration of inpatient labor induction as compared to women without pre-hospital cervical ripening.
Read the detailed description
Labor induction is a common procedure among pregnant patients at term. This process involves a period of cervical preparation ("ripening") for women who have an "unfavorable" cervical examination at the time labor induction is scheduled. Cervical ripening may take place with pharmacologic or mechanical strategies, which at this time are traditionally administered on an inpatient basis. This process can 24 or more hours, resulting in a lengthy hospitalization with the associated costs and frustrations for both patients and L\&D staff.
The proposed study is a randomized, controlled trial to explore the following research question: Among women with full-term pregnancies requiring labor induction, does pre-hospital, outpatient cervical ripening reduce the amount of inpatient time needed to achieve delivery as compared to no pre-hospital cervical ripening? As a secondary objective, we also wish to explore if outpatient cervical ripening is acceptable to patients.
This study will involve randomizing eligible and consenting women who have been scheduled for labor induction by their obstetrical providers into a pre-hospital cervical ripening (intervention) group or a no pre-hospital ripening (control) group. A trans-cervical Foley balloon (TCFB) will be used for outpatient pre-hospital cervical ripening in women randomized to the intervention group. No pre-hospital ripening will be performed for women in the control group. Both groups will be admitted for induction as scheduled and will undergo labor induction according to a specified, Bishop-score based induction protocol, which may or may not include a TCFB. We will compare the duration of inpatient stays from admission until delivery between the groups as well as satisfaction with the pre-hospital period and labor and delivery experience. Maternal and neonatal outcomes will also be compared between the two groups.
- Conditions
- Labor, Induced, Cervical Ripening
- Being tested
- Outpatient transcervical Foley balloon
- Keywords
- Induction of labor, Outpatient cervical ripening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient transcervical Foley balloonDevice
A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction.
| Study group | Role | What they receive |
|---|---|---|
| Usual Management | No intervention | Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis. |
| Outpatient transcervical Foley balloon | Experimental | Patients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols. Receives: Device: Outpatient transcervical Foley balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Inpatient Time Required to Achieve Delivery
Time from admission to the hospital until delivery
Measured: From admission to delivery, expected average of 48 hours
Secondary outcomes (1)
Maternal Satisfaction
Maternal satisfaction with the period leading up to admission and the hospital stay, measured by interview.
Measured: up to 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Inadequate enrollment. Key study personnel transitioned to a different role.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor, InducedStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten Salmeen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641601
- Sponsor's protocol ID
- 12-08620
- Acronym
- "PRIME"
- Status last verified
- Jul 2020
- First submitted
- 3 Jul 2012
- Last updated
- 5 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Prehospital Cervical Ripening With an Outpatient Transcervical Foley Balloon and the Duration of Induction and Maternal Satisfaction
- ClinicalTrials.gov ID
- NCT01641601
- Acronym / sponsor ID
- "PRIME" / 12-08620
- Conditions
- Labor, Induced, Cervical Ripening
- Keywords
- Induction of labor, Outpatient cervical ripening
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment. Key study personnel transitioned to a different role.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Posted 5 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized study evaluating the impact of pre-hospital cervical ripening with a transcervical Foley balloon before labor induction in full-term pregnancies on the length of inpatient labor induction and maternal satisfaction with the labor induction process. The investigators hypothesize that women who receive pre-hospital cervical ripening will have a shorter duration of inpatient labor induction as compared to women without pre-hospital cervical ripening.
Detailed description
Labor induction is a common procedure among pregnant patients at term. This process involves a period of cervical preparation ("ripening") for women who have an "unfavorable" cervical examination at the time labor induction is scheduled. Cervical ripening may take place with pharmacologic or mechanical strategies, which at this time are traditionally administered on an inpatient basis. This process can 24 or more hours, resulting in a lengthy hospitalization with the associated costs and frustrations for both patients and L\&D staff.
The proposed study is a randomized, controlled trial to explore the following research question: Among women with full-term pregnancies requiring labor induction, does pre-hospital, outpatient cervical ripening reduce the amount of inpatient time needed to achieve delivery as compared to no pre-hospital cervical ripening? As a secondary objective, we also wish to explore if outpatient cervical ripening is acceptable to patients.
This study will involve randomizing eligible and consenting women who have been scheduled for labor induction by their obstetrical providers into a pre-hospital cervical ripening (intervention) group or a no pre-hospital ripening (control) group. A trans-cervical Foley balloon (TCFB) will be used for outpatient pre-hospital cervical ripening in women randomized to the intervention group. No pre-hospital ripening will be performed for women in the control group. Both groups will be admitted for induction as scheduled and will undergo labor induction according to a specified, Bishop-score based induction protocol, which may or may not include a TCFB. We will compare the duration of inpatient stays from admission until delivery between the groups as well as satisfaction with the pre-hospital period and labor and delivery experience. Maternal and neonatal outcomes will also be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Management | No intervention | –Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis. |
| Outpatient transcervical Foley balloon | Experimental | Device: Outpatient transcervical Foley balloonPatients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Intrauterine pregnancy
- Cephalic presentation
- Greater than 36 weeks estimated gestational age
- Reassuring fetal status
- Normal amniotic fluid index
Key exclusion criteria (7 listed)
- Prior cesarean section
- Bishop score on cervical examination ≥ 6
- Unreliable transportation
- Home > 30 minutes from the hospital
- Non-reassuring fetal status
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 |
|---|---|---|
| Outpatient transcervical Foley balloonA 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction. | Device | Outpatient transcervical Foley balloon |
Primary outcome
Duration of Inpatient Time Required to Achieve Delivery
Time frame: From admission to delivery, expected average of 48 hours
Time from admission to the hospital until delivery
1 secondary outcome
Maternal Satisfaction
Time frame: up to 48 hours after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
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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.
Kirsten Salmeen, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient transcervical Foley balloon in people with Labor, Induced and Cervical Ripening, run by University of California, San Francisco at 1 site in United States.
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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Aug 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration of Inpatient Time Required to Achieve Delivery (time frame: From admission to delivery, expected average of 48 hours). 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 NCT01641601, which also lists 1 linked publication.
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 5 Aug 2020.