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出境医 / 临床实验 / Labor Protocol Study

Labor Protocol Study

Study Description
Brief Summary:
The goal of this study is to see if there is a better way to induce labor.

Condition or disease Intervention/treatment
Vaginal Delivery Labor Induced; Birth Drug: Cytotec Drug: oxytocin Device: Cervical Foley Balloon

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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 740 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of a Labor Induction Protocol on Vaginal Delivery Rate
Actual Study Start Date : March 30, 2021
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
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.
 Drug: Cytotec
Misoprostol 25mcg vaginal
Other Name: misoprostol

Drug: oxytocin
Oxytocin 10 IU/ml Solution for infusion
Other Name: Pitocin

Device: Cervical Foley Balloon
Cervical Foley will be inflated to 80cc
Outcome Measures
Primary Outcome Measures :
  1. Percentage of Vaginal Deliveries [ Time Frame: Within 24 hours ]
    Percent vaginal delivery within 24 hours of initiation of labor induction


Secondary Outcome Measures :
  1. Percent of vaginal delivery within 12 hours of initiating induction [ Time Frame: Within 12 hours ]
  2. Percent of deliveries (vaginal or cesarean) within 12 hours of initiating induction [ Time Frame: Within 12 hours ]
  3. Percent of deliveries (vaginal or cesarean) within 24 hours of initiating induction [ Time Frame: Within 24 hours ]
  4. Rate of vaginal delivery [ Time Frame: Within 4 days ]
  5. Rate of cesarean delivery [ Time Frame: Within 4 days ]
  6. Rate of operative vaginal delivery [ Time Frame: Within 4 days ]
  7. For patients undergoing cesarean delivery, rate of each indication for cesarean delivery [ Time Frame: Within 4 days ]
  8. Incidence of chorioamnionitis [ Time Frame: Within 4 days ]
  9. Number of vaginal exams [ Time Frame: Within 4 days ]
    mean, median

  10. Incidence of spontaneous internal version to non-cephalic presentation [ Time Frame: Within 4 days ]
  11. Incidence of umbilical cord prolapse [ Time Frame: Within 4 days ]
  12. Incidence of postpartum hemorrhage [ Time Frame: Within 7 days ]
  13. Incidence of transfusion of blood products [ Time Frame: Within 7 days ]
  14. Incidence of Neonatal 5-minute APGAR score <7 [ Time Frame: Within 4 days ]
  15. Incidence of Umbilical cord pH < 7, <7.1, <7.2 [ Time Frame: Within 4 days ]
  16. Incidence of Neonatal NICU admission [ Time Frame: Within 7 days ]
  17. Patient satisfaction with induction and delivery process measured on a scale of 1-10 - immediate [ Time Frame: During delivery hospitalization ]
    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.

  18. Incidence of shoulder dystocia [ Time Frame: Within 4 days ]
  19. Incidence of birth injuries (eg. brachial plexus injuries, musculoskeletal injuries, etc). [ Time Frame: Within 7 days ]
  20. Number of attending physicians managing induction of labor [ Time Frame: Within 4 days ]
  21. Number of attending-to-attending hand-off's [ Time Frame: Within 4 days ]
  22. Number of resident-to-resident team hand-off's [ Time Frame: Within 4 days ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with a single baby who are having their labor induced.
Criteria

Inclusion Criteria:

  1. Singleton pregnancy
  2. Cephalic presentation
  3. Gestational age 36 weeks 6 days- 42 weeks 0 days at initiation of induction of labor
  4. Age 18 and over

Exclusion Criteria:

  1. Preterm (less than 36 weeks 6 days) at initiation of induction of labor
  2. Non-cephalic presentation
  3. Major fetal anomalies or intrauterine fetal death
  4. Bishop score more than 6 at initiation of induction of labor
  5. 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).
  6. Any contraindication to vaginal delivery
  7. Latex allergic
Contacts and Locations

Locations
Layout table for location information
United States, New York
Montefiore Medical Center Weiler Division / Albert Einstein College of Medicine
Bronx, New York, United States, 10463
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Peter Bernstein, MD Montefiore Medical Center
Tracking Information
First Submitted Date June 27, 2019
First Posted Date July 2, 2019
Last Update Posted Date April 1, 2021
Actual Study Start Date March 30, 2021
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2019) 		Percentage of Vaginal Deliveries [ Time Frame: Within 24 hours ]
Percent vaginal delivery within 24 hours of initiation of labor induction
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 4, 2019)
  • 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 ]
    mean, median
  • 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 ]
    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.
  • 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 ]
Original Secondary Outcome Measures
 (submitted: June 28, 2019)
  • 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 ]
    mean, median
  • 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 one week ]
  • Incidence of transfusion of blood products [ Time Frame: Within one week ]
  • 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 one week ]
  • Patient satisfaction with induction and delivery process - immediate [ Time Frame: Up to 24 hours after delivery ]
  • Patient satisfaction with induction and delivery process measured on a scale of 1-10 [ Time Frame: Between 4 and 8 weeks postpartum ]
    mean, median
  • Incidence of shoulder dystocia [ Time Frame: Within 4 days ]
  • Incidence of birth injuries (eg. brachial plexus injuries, musculoskeletal injuries, etc). [ Time Frame: Within one week ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Labor Protocol Study
Official Title Effect of a Labor Induction Protocol on Vaginal Delivery Rate
Brief Summary 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant women with a single baby who are having their labor induced.
Condition
  • Vaginal Delivery
  • Labor
  • Induced; Birth
Intervention
  • Drug: Cytotec
    Misoprostol 25mcg vaginal
    Other Name: misoprostol
  • Drug: oxytocin
    Oxytocin 10 IU/ml Solution for infusion
    Other Name: Pitocin
  • Device: Cervical Foley Balloon
    Cervical Foley will be inflated to 80cc
Study Groups/Cohorts 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.
Interventions:
  • Drug: Cytotec
  • Drug: oxytocin
  • Device: Cervical Foley Balloon
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.
  • Pimentel 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.
  • Macones 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.
  • Wei 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;(8):CD006794. doi: 10.1002/14651858.CD006794.pub4. Review.
  • Battarbee, 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.
  • Mackeen 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. Erratum in: Obstet Gynecol. 2018 Apr;131(4):745.
  • Schoen 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.
  • Battarbee 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.
  • Yee 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.
  • Cahill 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.
  • Simpson 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.
  • American 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: November 4, 2019) 		740
Original Estimated Enrollment
 (submitted: June 28, 2019) 		415
Estimated Study Completion Date August 30, 2022
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Singleton pregnancy
  2. Cephalic presentation
  3. Gestational age 36 weeks 6 days- 42 weeks 0 days at initiation of induction of labor
  4. Age 18 and over

Exclusion Criteria:

  1. Preterm (less than 36 weeks 6 days) at initiation of induction of labor
  2. Non-cephalic presentation
  3. Major fetal anomalies or intrauterine fetal death
  4. Bishop score more than 6 at initiation of induction of labor
  5. 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).
  6. Any contraindication to vaginal delivery
  7. Latex allergic
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04004845
Other Study ID Numbers 2018-9662
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Peter S. Bernstein, Montefiore Medical Center
Study Sponsor Montefiore Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Peter Bernstein, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date March 2021

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