Vaginal DeliveryNCT04004845
Labor Protocol Study
An observational study of Vaginal Delivery and Labor, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The goal of this study is to see if there is a better way to induce labor. 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
- Vaginal Delivery, Labor, Induced; Birth
- What is being tested?
- Cytotec, oxytocin and Cervical Foley Balloon
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 1 Jun 2022
- Phase
- Observational
- 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
Study population: Pregnant women with a single baby who are having their labor induced.
Who may be able to join
- Singleton pregnancy
- Cephalic presentation
- Gestational age 36 weeks 6 days- 42 weeks 0 days at initiation of induction of labor
- Age 18 and over
Who cannot join
- Preterm (less than 36 weeks 6 days) at initiation of induction of labor
- Non-cephalic presentation
- Major fetal anomalies or intrauterine fetal death
- Bishop score more than 6 at initiation of induction of labor
- Any contraindication to any agents in the induction protocol (i.e. prior cesarean delivery or myomectomy, three or more contractions per ten minute period averaged over 30 minutes at the initiation of induction of labor, low lying placenta).
- Any contraindication to vaginal delivery
- Latex allergic
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center Weiler Division / Albert Einstein College of Medicine
The Bronx, New York, 10463
About this study
Official title: Effect of a Labor Induction Protocol on Vaginal Delivery Rate
The goal of this study is to see if there is a better way to induce labor.
Read the detailed description
This is quasi-experimental prospective cohort study with historical control to examine the efficacy of a new labor induction bundle. The prospective cohort will consist of all eligible nulliparous and multiparous patients admitted for induction; the historical control group will consist of all eligible nulliparous and multiparous patients admitted for induction between August 2019 and February 2020. Patients who are part of the prospective cohort who do not consent to the labor bundle due to personal or physician preferences will be included in secondary analyses as a contemporary control group, however the sample size of this group will not be determined in advance.
Objective: To assess if implementation of an evidence-based labor induction bundle will increase the rate of vaginal delivery within 24 hours.
Hypothesis: Implementation of a labor induction bundle would result in a 30% increase in the rate of vaginal delivery within 24 hours.
- Conditions
- Vaginal Delivery, Labor, Induced; Birth
- Being tested
- Cytotec, oxytocin, Cervical Foley Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytotecDrug
Also called misoprostol
Misoprostol 25mcg vaginal
oxytocinDrug
Also called Pitocin
Oxytocin 10 IU/ml Solution for infusion
Cervical Foley BalloonDevice
Cervical Foley will be inflated to 80cc
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | We are including only women who are age 18 or over, who have a single baby (not twins), with the baby's head down, and are between 36 weeks 6 days and 42 weeks 0 days of pregnancy. Receives: Drug: Cytotec; Drug: oxytocin; Device: Cervical Foley Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Vaginal Deliveries
Percent vaginal delivery within 24 hours of initiation of labor induction
Measured: Within 24 hours
Secondary outcomes (22)
Percent of vaginal delivery within 12 hours of initiating induction
Measured: Within 12 hours
Percent of deliveries (vaginal or cesarean) within 12 hours of initiating induction
Measured: Within 12 hours
Percent of deliveries (vaginal or cesarean) within 24 hours of initiating induction
Measured: Within 24 hours
Rate of vaginal delivery
Measured: Within 4 days
Rate of cesarean delivery
Measured: Within 4 days
Rate of operative vaginal delivery
Measured: Within 4 days
For patients undergoing cesarean delivery, rate of each indication for cesarean delivery
Measured: Within 4 days
Incidence of chorioamnionitis
Measured: Within 4 days
Number of vaginal exams
mean, median
Measured: Within 4 days
Incidence of spontaneous internal version to non-cephalic presentation
Measured: Within 4 days
Incidence of umbilical cord prolapse
Measured: Within 4 days
Incidence of postpartum hemorrhage
Measured: Within 7 days
Incidence of transfusion of blood products
Measured: Within 7 days
Incidence of Neonatal 5-minute APGAR score <7
Measured: Within 4 days
Incidence of Umbilical cord pH < 7, <7.1, <7.2
Measured: Within 4 days
Incidence of Neonatal NICU admission
Measured: Within 7 days
Patient satisfaction with induction and delivery process measured on a scale of 1-10 - immediate
Will analyze mean, median. Scale 1, 2, 3, 4, 5, 6, 7, 8, 9, 10. Minimum score 1, Maximum score 10. A score of 1 is considered a worse outcome (completely dissatisfied) and 10 is considered a better outcome (completely satisfied). A score of 5 is neutral.
Measured: During delivery hospitalization
Incidence of shoulder dystocia
Measured: Within 4 days
Incidence of birth injuries (eg. brachial plexus injuries, musculoskeletal injuries, etc).
Measured: Within 7 days
Number of attending physicians managing induction of labor
Measured: Within 4 days
Number of attending-to-attending hand-off's
Measured: Within 4 days
Number of resident-to-resident team hand-off's
Measured: Within 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start30 Mar 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Why it stopped: Study was temporarily paused due to COVID19 and ultimately terminated at the discretion of the PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Vaginal DeliveryStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter S. Bernstein, Montefiore Medical Center
- Investigators
- Peter Bernstein, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004845
- Sponsor's protocol ID
- 2018-9662
- Status last verified
- Oct 2022
- First submitted
- 27 Jun 2019
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
How HY, Leaseburge L, Khoury JC, Siddiqi TA, Spinnato JA, Sibai BM. A comparison of various routes and dosages of misoprostol for cervical ripening and the induction of labor. Am J Obstet Gynecol. 2001 Oct;185(4):911-5. doi: 10.1067/mob.2001.117358.
PubMed 11641677Pimentel VM, Arabkhazaeli M, Moon JY, Wang A, Kapedani A, Bernstein PS, Tropper PJ. Induction of labor using one dose vs multiple doses of misoprostol: a randomized controlled trial. Am J Obstet Gynecol. 2018 Jun;218(6):614.e1-614.e8. doi: 10.1016/j.ajog.2018.03.034. Epub 2018 Mar 31.
PubMed 29614276Macones GA, Cahill A, Stamilio DM, Odibo AO. The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):403.e1-5. doi: 10.1016/j.ajog.2012.08.032. Epub 2012 Aug 24.
PubMed 22959833Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 2013 Aug 7;2013(8):CD006794. doi: 10.1002/14651858.CD006794.pub4.
PubMed 23926074Battarbee, A.N., Maternal and neonatal outcomes associated with early amniotomy in term nulliparous labor induction. Am J Obstet Gynecol, 2019. 220: p. 1.
Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.
PubMed 27824758Mackeen AD, Durie DE, Lin M, Huls CK, Qureshey E, Paglia MJ, Sun H, Sciscione A. Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):4-11. doi: 10.1097/AOG.0000000000002374.
PubMed 29215519Schoen CN, Saccone G, Backley S, Sandberg EM, Gu N, Delaney S, Berghella V. Increased single-balloon Foley catheter volume for induction of labor and time to delivery: a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2018 Sep;97(9):1051-1060. doi: 10.1111/aogs.13353. Epub 2018 Apr 25.
PubMed 29607491Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.
PubMed 27500341Yee LM, Sandoval G, Bailit J, Reddy UM, Wapner RJ, Varner MW, Caritis SN, Prasad M, Tita ATN, Saade G, Sorokin Y, Rouse DJ, Blackwell SC, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Maternal and Neonatal Outcomes With Early Compared With Delayed Pushing Among Nulliparous Women. Obstet Gynecol. 2016 Nov;128(5):1039-1047. doi: 10.1097/AOG.0000000000001683.
PubMed 27741203Cahill AG, Srinivas SK, Tita ATN, Caughey AB, Richter HE, Gregory WT, Liu J, Woolfolk C, Weinstein DL, Mathur AM, Macones GA, Tuuli MG. Effect of Immediate vs Delayed Pushing on Rates of Spontaneous Vaginal Delivery Among Nulliparous Women Receiving Neuraxial Analgesia: A Randomized Clinical Trial. JAMA. 2018 Oct 9;320(14):1444-1454. doi: 10.1001/jama.2018.13986.
PubMed 30304425Simpson LL, Rochelson B, Ananth CV, Bernstein PS, D'Alton M, Chazotte C, Lavery JA, Zielinski K; Safe Motherhood Initiative Severe Hypertension in Pregnancy Work Group. Safe Motherhood Initiative: Early Impact of Severe Hypertension in Pregnancy Bundle Implementation. AJP Rep. 2018 Oct;8(4):e212-e218. doi: 10.1055/s-0038-1673632. Epub 2018 Oct 11.
PubMed 30319925American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine; Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2014 Mar;210(3):179-93. doi: 10.1016/j.ajog.2014.01.026.
PubMed 24565430
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Labor Induction Protocol on Vaginal Delivery Rate
- ClinicalTrials.gov ID
- NCT04004845
- Acronym / sponsor ID
- 2018-9662
- Conditions
- Vaginal Delivery, Labor, Induced; Birth
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was temporarily paused due to COVID19 and ultimately terminated at the discretion of the PI
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 2 Jul 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.
The goal of this study is to see if there is a better way to induce labor.
Detailed description
This is quasi-experimental prospective cohort study with historical control to examine the efficacy of a new labor induction bundle. The prospective cohort will consist of all eligible nulliparous and multiparous patients admitted for induction; the historical control group will consist of all eligible nulliparous and multiparous patients admitted for induction between August 2019 and February 2020. Patients who are part of the prospective cohort who do not consent to the labor bundle due to personal or physician preferences will be included in secondary analyses as a contemporary control group, however the sample size of this group will not be determined in advance.
Objective: To assess if implementation of an evidence-based labor induction bundle will increase the rate of vaginal delivery within 24 hours.
Hypothesis: Implementation of a labor induction bundle would result in a 30% increase in the rate of vaginal delivery within 24 hours.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Drug: Cytotec, Drug: oxytocin, Device: Cervical Foley BalloonWe are including only women who are age 18 or over, who have a single baby (not twins), with the baby's head down, and are between 36 weeks 6 days and 42 weeks 0 days of pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with a single baby who are having their labor induced.
Key inclusion criteria (4 listed)
- Singleton pregnancy
- Cephalic presentation
- Gestational age 36 weeks 6 days- 42 weeks 0 days at initiation of induction of labor
- Age 18 and over
Key exclusion criteria (7 listed)
- Preterm (less than 36 weeks 6 days) at initiation of induction of labor
- Non-cephalic presentation
- Major fetal anomalies or intrauterine fetal death
- Bishop score more than 6 at initiation of induction of labor
- Any contraindication to any agents in the induction protocol (i.e. prior cesarean delivery or myomectomy, three or more contractions per ten minute period averaged over 30 minutes at the initiation of induction of labor, low lying placenta).
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 |
|---|---|---|
| CytotecAlso: misoprostolMisoprostol 25mcg vaginal | Drug | Pregnant women |
| oxytocinAlso: PitocinOxytocin 10 IU/ml Solution for infusion | Drug | Pregnant women |
| Cervical Foley BalloonCervical Foley will be inflated to 80cc | Device | Pregnant women |
Primary outcome
Percentage of Vaginal Deliveries
Time frame: Within 24 hours
Percent vaginal delivery within 24 hours of initiation of labor induction
22 secondary outcomes
Percent of vaginal delivery within 12 hours of initiating induction
Time frame: Within 12 hours
Percent of deliveries (vaginal or cesarean) within 12 hours of initiating induction
Time frame: Within 12 hours
Percent of deliveries (vaginal or cesarean) within 24 hours of initiating induction
Time frame: Within 24 hours
Rate of vaginal delivery
Time frame: Within 4 days
Rate of cesarean delivery
Time frame: Within 4 days
Rate of operative vaginal delivery
Time frame: Within 4 days
For patients undergoing cesarean delivery, rate of each indication for cesarean delivery
Time frame: Within 4 days
Incidence of chorioamnionitis
Time frame: Within 4 days
Number of vaginal exams
Time frame: Within 4 days
Incidence of spontaneous internal version to non-cephalic presentation
Time frame: Within 4 days
Incidence of umbilical cord prolapse
Time frame: Within 4 days
Incidence of postpartum hemorrhage
Time frame: Within 7 days
Incidence of transfusion of blood products
Time frame: Within 7 days
Incidence of Neonatal 5-minute APGAR score <7
Time frame: Within 4 days
Incidence of Umbilical cord pH < 7, <7.1, <7.2
Time frame: Within 4 days
Incidence of Neonatal NICU admission
Time frame: Within 7 days
Patient satisfaction with induction and delivery process measured on a scale of 1-10 - immediate
Time frame: During delivery hospitalization
Incidence of shoulder dystocia
Time frame: Within 4 days
Incidence of birth injuries (eg. brachial plexus injuries, musculoskeletal injuries, etc).
Time frame: Within 7 days
Number of attending physicians managing induction of labor
Time frame: Within 4 days
Number of attending-to-attending hand-off's
Time frame: Within 4 days
Number of resident-to-resident team hand-off's
Time frame: Within 4 days
Results and safety
The study was stopped early (reason given: Study was temporarily paused due to COVID19 and ultimately terminated at the discretion of the PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Background: PubMed 11641677How HY, Leaseburge L, Khoury JC, Siddiqi TA, Spinnato JA, Sibai BM. A comparison of various routes and dosages of misoprostol for cervical ripening and the induction of labor. Am J Obstet Gynecol. 2001 Oct;185(4):911-5. doi: 10.1067/mob.2001.117358.
- Background: PubMed 29614276Pimentel VM, Arabkhazaeli M, Moon JY, Wang A, Kapedani A, Bernstein PS, Tropper PJ. Induction of labor using one dose vs multiple doses of misoprostol: a randomized controlled trial. Am J Obstet Gynecol. 2018 Jun;218(6):614.e1-614.e8. doi: 10.1016/j.ajog.2018.03.034. Epub 2018 Mar 31.
- Background: PubMed 22959833Macones GA, Cahill A, Stamilio DM, Odibo AO. The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):403.e1-5. doi: 10.1016/j.ajog.2012.08.032. Epub 2012 Aug 24.
- Background: PubMed 23926074Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 2013 Aug 7;2013(8):CD006794. doi: 10.1002/14651858.CD006794.pub4.
- BackgroundBattarbee, A.N., Maternal and neonatal outcomes associated with early amniotomy in term nulliparous labor induction. Am J Obstet Gynecol, 2019. 220: p. 1.
- Background: PubMed 27824758Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.
- Background: PubMed 29215519Mackeen AD, Durie DE, Lin M, Huls CK, Qureshey E, Paglia MJ, Sun H, Sciscione A. Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):4-11. doi: 10.1097/AOG.0000000000002374.
- Background: PubMed 29607491Schoen CN, Saccone G, Backley S, Sandberg EM, Gu N, Delaney S, Berghella V. Increased single-balloon Foley catheter volume for induction of labor and time to delivery: a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2018 Sep;97(9):1051-1060. doi: 10.1111/aogs.13353. Epub 2018 Apr 25.
- Background: PubMed 27500341Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.
- Background: PubMed 27741203Yee LM, Sandoval G, Bailit J, Reddy UM, Wapner RJ, Varner MW, Caritis SN, Prasad M, Tita ATN, Saade G, Sorokin Y, Rouse DJ, Blackwell SC, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Maternal and Neonatal Outcomes With Early Compared With Delayed Pushing Among Nulliparous Women. Obstet Gynecol. 2016 Nov;128(5):1039-1047. doi: 10.1097/AOG.0000000000001683.
- Background: PubMed 30304425Cahill AG, Srinivas SK, Tita ATN, Caughey AB, Richter HE, Gregory WT, Liu J, Woolfolk C, Weinstein DL, Mathur AM, Macones GA, Tuuli MG. Effect of Immediate vs Delayed Pushing on Rates of Spontaneous Vaginal Delivery Among Nulliparous Women Receiving Neuraxial Analgesia: A Randomized Clinical Trial. JAMA. 2018 Oct 9;320(14):1444-1454. doi: 10.1001/jama.2018.13986.
- Background: PubMed 30319925Simpson LL, Rochelson B, Ananth CV, Bernstein PS, D'Alton M, Chazotte C, Lavery JA, Zielinski K; Safe Motherhood Initiative Severe Hypertension in Pregnancy Work Group. Safe Motherhood Initiative: Early Impact of Severe Hypertension in Pregnancy Bundle Implementation. AJP Rep. 2018 Oct;8(4):e212-e218. doi: 10.1055/s-0038-1673632. Epub 2018 Oct 11.
- Individual participant dataSharing planned: No
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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.
Peter Bernstein, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Delivery and Labor, run by Montefiore Medical Center 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 4 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 4 Oct 2022. 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 stopped early (reason given: Study was temporarily paused due to COVID19 and ultimately terminated at the discretion of the PI). Results are not available in the source record.
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?
Percentage of Vaginal Deliveries (time frame: Within 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 NCT04004845, which also lists 13 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 4 Oct 2022.