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Labor Protocol Study

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ClinicalTrials.gov Identifier: NCT04004845
Recruitment Status : Suspended (Temporarily paused due to COVID19, expected to resume. This is not a suspension of IRB approval)
First Posted : July 2, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Peter S. Bernstein, Montefiore Medical Center

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.

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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 : October 3, 2019
Estimated Primary Completion Date : August 13, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004845


Locations
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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
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Principal Investigator: Peter Bernstein, MD Montefiore Medical Center
Publications:
Battarbee, A.N., Maternal and neonatal outcomes associated with early amniotomy in term nulliparous labor induction. Am J Obstet Gynecol, 2019. 220: p. 1.

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Responsible Party: Peter S. Bernstein, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT04004845    
Other Study ID Numbers: 2018-9662
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Misoprostol
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents