Cervical RipeningOCPRIDNCT03934918
Outpatient Cervical Preparation to Reduce Induction Duration in NTSV Women
A study testing Treatment in people with Cervical Ripening and Outpatient, run by University of California, Davis at 1 site in United States.
Trial summary
This study is to compare 2 groups in nulliparous women undergoing cervical ripening for induction of labor. The study hypothesis is that outpatient cervical preparation with a foley catheter can reduce the induction of labor (IOL) time interval from admission to delivery by 50%. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Ripening, Outpatient, Patient Satisfaction
- What is being tested?
- Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2020to Jun 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nulliparous women >18 years of age
- Singleton live pregnancy
- Vertex presentation
- Scheduled induction of labor between 37 and 42 weeks gestation
- Bishop score <6
Who cannot join
- Regular painful contractions (> every 5 minutes)
- Oligohydramnios or anhydramnios
- Breech presentation
- Rupture of membranes
- Fetal heart tracing with minimal variability or significant decelerations with >50% contractions
- Prior vaginal or cesarean delivery
Show all 11Show fewer
- Contraindication to vaginal delivery (including placenta previa, morbidly adherent placenta, active genital herpes)
- Known or suspected placental abruption
- Major fetal anomaly
- Poorly controlled hypertension (using 2 or more medications; newly diagnosed preeclampsia; preeclampsia with severe features; superimposed preeclampsia)
- Poorly controlled diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Sacramento, California, 95817
About this study
Official title: Outpatient Cervical Preparation to Reduce Induction Duration in Nulliparous Term Singleton Vertex Women: A Randomized Controlled Trial
This study is to compare 2 groups in nulliparous women undergoing cervical ripening for induction of labor. The study hypothesis is that outpatient cervical preparation with a foley catheter can reduce the induction of labor (IOL) time interval from admission to delivery by 50%. A 30 ml transcervical foley catheter is a safe mode of cervical preparation in the outpatient setting, as concluded in Diederen et al, Sciscinoe et al, and Kelly et al. Findings from studies on nulliparous, term, singleton vertex (NTSV) showed patients can be applied to a wide variety of maternity unit sizes as discussed by Main et al. No previous study has evaluated the effectiveness of outpatient cervical preparation in the NTSV population by PUBMED search. Further, no previous study has assessed patient satisfaction cervical preparation in the outpatient setting and no previous study has evaluated whether outpatient cervical preparation has an impact on the length of stay and cost of hospitalization. This study will explore these important questions with the goal of improving current practices in labor induction to be more patient-centered, pragmatic, and cost-effective.
Read the detailed description
Each participant who is offered an induction of labor from the University of California (UC) Davis Obstetrics and Gynecology clinics will be screened for inclusion criteria. If the participant meets inclusion criteria the participant will be given general information about the study and asked if they would like to participate. If so, research coordinators will meet the participant either during the current clinic visit or a subsequent clinic visit to consent and enroll the participant in the study. During this meeting, the participant will be randomly assigned to Group 1 or Group 2 by using randomization.com and subject number.
Group 1: Treatment
The participant will be given an appointment for fetal monitoring and transcervical foley catheter placement at the Antenatal Testing Unit of the UC Davis Ambulatory Care Center. This may be a same-day appointment. Once the participant presents for her appointment, participant will undergo a routine cervical examination, and routine ultrasound examination for fetal presentation and deep vertical pocket. The participant will also have vitals taken and undergo a brief interview with a provider to rule out rupture of membranes, significant vaginal bleeding, and other perinatal concerns. In order to undergo outpatient cervical preparation, the participant must meet the following criteria: Bishop's score <6 on cervical exam; Normal deep vertical pocket; Cephalic presentation; Negative standard interview to screen for vaginal bleeding, rupture of membranes, labor, and pre-eclampsia; and Blood pressure below 160 bpm systolic and 110 bpm diastolic.
If the participant meets the above criteria for outpatient cervical preparation, a 30 mL transcervical foley catheter will be placed. If the participant does not meet criteria, participant will be sent to Labor and Delivery for possible admission. The participant may elect to receive pain medication intramuscularly for pain management before or after foley catheter placement. After catheter placement the participant will undergo a nonstress test (NST), and if there is no evidence of tachysystole or non-reassuring fetal well-being, participant will be discharged home with a prescription for tylenol. Upon discharge home, the participant will receive instructions on keeping catheter on gentle traction and walking. The participant will be instructed to return once the foley is expelled, or after 24 hours with the foley in place. The participant will also leave with return precautions including rupture of membranes, vaginal bleeding, decreased fetal movement, labor, severe pain, and signs or symptoms of preeclampsia. As a safety measure, the participant will be counseled to call an 24 hour advice nurse line if participant experiences any of the following: Severe pain or discomfort (greater than 8 out of a 10 point scale); Vaginal bleeding; Loss of fluid; Contractions more than 5 minutes apart; Decreased fetal movement; Fevers or chills; Severe headache; Abdominal pain under right rib area; and Spots in vision or blurry vision.
The remaining procedures in this group will follow the standard Labor and Delivery hospital procedures at UC Davis
Group 2: Control The participant will be admitted to Labor and Delivery. The remaining procedures in this group will follow standard Labor and Delivery hospital procedures at UC Davis
The duration anticipated to enroll all study subjects is 10-14 months after Institutional Review Board approval. Approximately 30-40 participant are admitted each month to UC Davis Labor and Delivery. On average, half of these participants are nulliparous. If approximately 5- 10 participants are recruited to each group each month, it will take 10-14 months to reach the goal number of subjects. The duration of an individual subject's participation in the study will be from time of foley catheter insertion (Group 1) or hospital admission time (Group 2) to the time of hospital discharge. Electronic medical records will be accessed during and after this time period only pertaining to the participant's labor including intrapartum and postpartum complications. In addition, participants will be asked survey questions at the time of study enrollment and on postpartum day 1. The estimated date for the investigators to complete this study is two months after enrollment has ended.
- Conditions
- Cervical Ripening, Outpatient, Patient Satisfaction, Nulliparous, Length of Stay
- Being tested
- Treatment
- Keywords
- cervical preparation, cervical ripening, NTSV, induction of labor
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
Patients for IOL are sent home after placement of intracervical balloon
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients for IOL with intracervical balloon placed in the outpatient clinic and sent home Receives: Other: Treatment |
| Control | No intervention | Patients for IOL admitted to Labor and Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of time from admission for IOL to delivery
The time difference from admission to delivery of the infant
Measured: 24 hours
Secondary outcomes (5)
Total time of oxytocin use
time from start to discontinuation prior to delivery
Measured: 24 hours
Cesarean delivery
proportion of cesarean section
Measured: 12 months
Blood transfusion
binary - yes or no
Measured: 12 months
Neonatal intensive care unit (NICU) admission
Binary - yes or no
Measured: 12 months
Apgar score at 5 minutes less than 7
Binary - yes or no
Measured: 5 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study startDec 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: Lack of enrollment \& funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cervical RipeningStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Model description
- Comparing the duration from admission to delivery in nulliparous women between outpatient cervical ripening and those who were admitted for induction of labor
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herman L Hedriana, MD, Principal investigator, University of California Davis Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934918
- Sponsor's protocol ID
- 1233410
- Acronym
- OCPRID
- Status last verified
- Mar 2021
- First submitted
- 18 Apr 2019
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Society of Maternal-Fetal (SMFM) Publications Committee. Electronic address: pubs@smfm.org. SMFM Statement on Elective Induction of Labor in Low-Risk Nulliparous Women at Term: the ARRIVE Trial. Am J Obstet Gynecol. 2019 Jul;221(1):B2-B4. doi: 10.1016/j.ajog.2018.08.009. Epub 2018 Aug 9.
PubMed 30098985Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG. 2018 Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10.
PubMed 29211328Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
PubMed 11704164Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007372. doi: 10.1002/14651858.CD007372.pub3.
PubMed 24222365Main EK. Leading Change on Labor and Delivery: Reducing Nulliparous Term Singleton Vertex (NTSV) Cesarean Rates. Jt Comm J Qual Patient Saf. 2017 Feb;43(2):51-52. doi: 10.1016/j.jcjq.2016.11.009. Epub 2016 Nov 15. No abstract available.
PubMed 28334562Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
PubMed 32852803
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Cervical Preparation to Reduce Induction Duration in Nulliparous Term Singleton Vertex Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03934918
- Acronym / sponsor ID
- OCPRID / 1233410
- Conditions
- Cervical Ripening, Outpatient, Patient Satisfaction, Nulliparous, Length of Stay
- Keywords
- cervical preparation, cervical ripening, NTSV, induction of labor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment \& funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 2 May 2019 (actual)
- 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 is to compare 2 groups in nulliparous women undergoing cervical ripening for induction of labor. The study hypothesis is that outpatient cervical preparation with a foley catheter can reduce the induction of labor (IOL) time interval from admission to delivery by 50%. A 30 ml transcervical foley catheter is a safe mode of cervical preparation in the outpatient setting, as concluded in Diederen et al, Sciscinoe et al, and Kelly et al. Findings from studies on nulliparous, term, singleton vertex (NTSV) showed patients can be applied to a wide variety of maternity unit sizes as discussed by Main et al. No previous study has evaluated the effectiveness of outpatient cervical preparation in the NTSV population by PUBMED search. Further, no previous study has assessed patient satisfaction cervical preparation in the outpatient setting and no previous study has evaluated whether outpatient cervical preparation has an impact on the length of stay and cost of hospitalization. This study will explore these important questions with the goal of improving current practices in labor induction to be more patient-centered, pragmatic, and cost-effective.
Detailed description
Each participant who is offered an induction of labor from the University of California (UC) Davis Obstetrics and Gynecology clinics will be screened for inclusion criteria. If the participant meets inclusion criteria the participant will be given general information about the study and asked if they would like to participate. If so, research coordinators will meet the participant either during the current clinic visit or a subsequent clinic visit to consent and enroll the participant in the study. During this meeting, the participant will be randomly assigned to Group 1 or Group 2 by using randomization.com and subject number.
Group 1: Treatment
The participant will be given an appointment for fetal monitoring and transcervical foley catheter placement at the Antenatal Testing Unit of the UC Davis Ambulatory Care Center. This may be a same-day appointment. Once the participant presents for her appointment, participant will undergo a routine cervical examination, and routine ultrasound examination for fetal presentation and deep vertical pocket. The participant will also have vitals taken and undergo a brief interview with a provider to rule out rupture of membranes, significant vaginal bleeding, and other perinatal concerns. In order to undergo outpatient cervical preparation, the participant must meet the following criteria: Bishop's score <6 on cervical exam; Normal deep vertical pocket; Cephalic presentation; Negative standard interview to screen for vaginal bleeding, rupture of membranes, labor, and pre-eclampsia; and Blood pressure below 160 bpm systolic and 110 bpm diastolic.
If the participant meets the above criteria for outpatient cervical preparation, a 30 mL transcervical foley catheter will be placed. If the participant does not meet criteria, participant will be sent to Labor and Delivery for possible admission. The participant may elect to receive pain medication intramuscularly for pain management before or after foley catheter placement. After catheter placement the participant will undergo a nonstress test (NST), and if there is no evidence of tachysystole or non-reassuring fetal well-being, participant will be discharged home with a prescription for tylenol. Upon discharge home, the participant will receive instructions on keeping catheter on gentle traction and walking. The participant will be instructed to return once the foley is expelled, or after 24 hours with the foley in place. The participant will also leave with return precautions including rupture of membranes, vaginal bleeding, decreased fetal movement, labor, severe pain, and signs or symptoms of preeclampsia. As a safety measure, the participant will be counseled to call an 24 hour advice nurse line if participant experiences any of the following: Severe pain or discomfort (greater than 8 out of a 10 point scale); Vaginal bleeding; Loss of fluid; Contractions more than 5 minutes apart; Decreased fetal movement; Fevers or chills; Severe headache; Abdominal pain under right rib area; and Spots in vision or blurry vision.
The remaining procedures in this group will follow the standard Labor and Delivery hospital procedures at UC Davis
Group 2: Control The participant will be admitted to Labor and Delivery. The remaining procedures in this group will follow standard Labor and Delivery hospital procedures at UC Davis
The duration anticipated to enroll all study subjects is 10-14 months after Institutional Review Board approval. Approximately 30-40 participant are admitted each month to UC Davis Labor and Delivery. On average, half of these participants are nulliparous. If approximately 5- 10 participants are recruited to each group each month, it will take 10-14 months to reach the goal number of subjects. The duration of an individual subject's participation in the study will be from time of foley catheter insertion (Group 1) or hospital admission time (Group 2) to the time of hospital discharge. Electronic medical records will be accessed during and after this time period only pertaining to the participant's labor including intrapartum and postpartum complications. In addition, participants will be asked survey questions at the time of study enrollment and on postpartum day 1. The estimated date for the investigators to complete this study is two months after enrollment has ended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparing the duration from admission to delivery in nulliparous women between outpatient cervical ripening and those who were admitted for induction of labor
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: TreatmentPatients for IOL with intracervical balloon placed in the outpatient clinic and sent home |
| Control | No intervention | –Patients for IOL admitted to Labor and Delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Nulliparous women >18 years of age
- Singleton live pregnancy
- Vertex presentation
- Scheduled induction of labor between 37 and 42 weeks gestation
- Bishop score <6
Key exclusion criteria (11 listed)
- Regular painful contractions (> every 5 minutes)
- Oligohydramnios or anhydramnios
- Breech presentation
- Rupture of membranes
- Fetal heart tracing with minimal variability or significant decelerations with >50% contractions
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 |
|---|---|---|
| TreatmentPatients for IOL are sent home after placement of intracervical balloon | Other | Treatment |
Primary outcome
Duration of time from admission for IOL to delivery
Time frame: 24 hours
The time difference from admission to delivery of the infant
5 secondary outcomes
Total time of oxytocin use
Time frame: 24 hours
Cesarean delivery
Time frame: 12 months
Blood transfusion
Time frame: 12 months
Neonatal intensive care unit (NICU) admission
Time frame: 12 months
Apgar score at 5 minutes less than 7
Time frame: 5 minutes after birth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Results publication: PubMed 30098985Society of Maternal-Fetal (SMFM) Publications Committee. Electronic address: pubs@smfm.org. SMFM Statement on Elective Induction of Labor in Low-Risk Nulliparous Women at Term: the ARRIVE Trial. Am J Obstet Gynecol. 2019 Jul;221(1):B2-B4. doi: 10.1016/j.ajog.2018.08.009. Epub 2018 Aug 9.
- Results publication: PubMed 29211328Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG. 2018 Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10.
- Results publication: PubMed 11704164Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
- Results publication: PubMed 24222365Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007372. doi: 10.1002/14651858.CD007372.pub3.
- Results publication: PubMed 28334562Main EK. Leading Change on Labor and Delivery: Reducing Nulliparous Term Singleton Vertex (NTSV) Cesarean Rates. Jt Comm J Qual Patient Saf. 2017 Feb;43(2):51-52. doi: 10.1016/j.jcjq.2016.11.009. Epub 2016 Nov 15. No abstract available.
- Derived from this study: PubMed 32852803Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
- Individual participant dataSharing planned: No
Related trials for Cervical Ripening
RecruitingPhase 2/3
Impact of Standardization on Outcomes Following Cervical Ripening
Pregnancy
Recruiting
Cervical Ripening Balloons for Same-Day Cervical Prep
Dilation and Evacuation
Not yet recruiting
Improving the Childbirth Experience for Women Who Have Undergone Cervical Ripening by Involving Them in the Choice of Ripening Technique
Pregnancy, Cervical Ripening
Not yet recruiting
Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
Induced Labor, Cervical Ripening
Not yet recruiting
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
Induced; Birth
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.
Herman L Hedriana, MD principal investigator
University of California Davis Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Cervical Ripening and Outpatient, run by University of California, Davis 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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 5 Apr 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 time from admission for IOL to delivery (time frame: 24 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 NCT03934918, which also lists 6 linked publications.
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 Apr 2021.