Labor Protocol Study

NCT04004845 | Terminated DMC FDA Drug FDA Device

• 1 other identifier: 2018-9662
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to see if there is a better way to induce labor.

Conditions

Vaginal Delivery; Labor; Induced; Birth

Outcome Measures

Primary Outcomes (1)

• Percentage of Vaginal Deliveries

  Percent vaginal delivery within 24 hours of initiation of labor induction

  Within 24 hours

Secondary Outcomes (22)

• Percent of vaginal delivery within 12 hours of initiating induction

  Within 12 hours

• Percent of deliveries (vaginal or cesarean) within 12 hours of initiating induction

  Within 12 hours

• Percent of deliveries (vaginal or cesarean) within 24 hours of initiating induction

  Within 24 hours

• Rate of vaginal delivery

  Within 4 days

• Rate of cesarean delivery

  Within 4 days

Study Arms (1)

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; Drug: oxytocin; Device: Cervical Foley Balloon

Interventions

Cytotec DRUG

Misoprostol 25mcg vaginal

Also known as: misoprostol

Pregnant women

oxytocin DRUG

Oxytocin 10 IU/ml Solution for infusion

Also known as: Pitocin

Pregnant women

Cervical Foley Balloon DEVICE

Cervical Foley will be inflated to 80cc

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with a single baby who are having their labor induced.

You may qualify if:

• Singleton pregnancy
• Cephalic presentation
• Gestational age 36 weeks 6 days- 42 weeks 0 days at initiation of induction of labor
• Age 18 and over

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center Weiler Division / Albert Einstein College of Medicine

The Bronx, New York, 10463, United States

Location

Related Publications (13)

• 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.

  PMID: 11641677 BACKGROUND

• 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.

  PMID: 29614276 BACKGROUND

• 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.

  PMID: 22959833 BACKGROUND

• 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;2013(8):CD006794. doi: 10.1002/14651858.CD006794.pub4.

  PMID: 23926074 BACKGROUND

• Battarbee, A.N., Maternal and neonatal outcomes associated with early amniotomy in term nulliparous labor induction. Am J Obstet Gynecol, 2019. 220: p. 1.

  BACKGROUND

• 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.

  PMID: 27824758 BACKGROUND

• 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.

  PMID: 29215519 BACKGROUND

• 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.

  PMID: 29607491 BACKGROUND

• 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.

  PMID: 27500341 BACKGROUND

• 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.

  PMID: 27741203 BACKGROUND

• 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.

  PMID: 30304425 BACKGROUND

• 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.

  PMID: 30319925 BACKGROUND

• 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.

  PMID: 24565430 BACKGROUND

MeSH Terms

Interventions

Misoprostol; Oxytocin

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Peter Bernstein, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 2, 2019
• Study Start: March 30, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)