Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor

This study has been terminated.
(Poor Enrollment)
Sponsor:
Information provided by (Responsible Party):
Ram Parvataneni MD, MPH, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01519765
First received: January 5, 2012
Last updated: August 3, 2016
Last verified: August 2016
  Purpose
Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue, is a widely accepted induction agent, that has been proven safe and effective for induction of labor. It stimulates both cervical ripening and uterine contractions, thus making it an ideal induction agent for unfavorable cervices. Research has examined the pharmacokinetics of different administration routes and effects on uterine contractility, side effects, and safety. Vaginal misoprostol has been shown to be superior over oral administration however patients often prefer a more tolerable route. Buccal administration has already been shown to be as effective as vaginal misoprostol for cervical ripening and induction in both first trimester and second trimester abortions. There is minimal research comparing buccal versus vaginal for third trimester induction of labor. The investigators study is a prospective, double blinded, randomized control trial comparing vaginal misoprostol and buccal misoprostol in equal dosages of 25 mcg. The investigators seek to answer the question whether buccal misoprostol is as effective as vaginal misoprostol for third trimester induction of labor.

Condition Intervention Phase
Pregnancy
Drug: Buccal Misoprostol
Drug: Vaginal misoprostol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor: Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Vaginal Delivery Within 24 Hours of Labor Induction [ Time Frame: Within 24 hours of labor induction ] [ Designated as safety issue: No ]
    Percentage of participants able to achieve vaginal delivery within 24 hours of labor induction.


Secondary Outcome Measures:
  • Time to Vaginal Delivery [ Time Frame: Start of induction until vaginal delivery ] [ Designated as safety issue: No ]
    Time from start of induction to vaginal delivery was computed in participants who achieved vaginal delivery.

  • Time to Delivery [ Time Frame: Until delivery ] [ Designated as safety issue: No ]
    Time from induction to delivery. All participants were included.

  • Time to Active Labor [ Time Frame: Until active labor ] [ Designated as safety issue: No ]
    Time from induction to active labor. Active labor defined as 4 cm and above. P-value computed by Kruskal-Wallis test.

  • Rates of Vaginal Delivery [ Time Frame: Until delivery ] [ Designated as safety issue: No ]
    Percentage of participants who delivered vaginally

  • Cesarean Delivery Rate [ Time Frame: Until delivery ] [ Designated as safety issue: No ]
    Percentage of participants who underwent a cesarean delivery was computed. P-value was computed using Fisher's exact test.

  • Number of Misoprostol Doses [ Time Frame: Until delivery ] [ Designated as safety issue: No ]
    Number of misoprostol 25 mcg doses used during induction of labor.

  • Arrest of Dilation [ Time Frame: Until delivery ] [ Designated as safety issue: No ]

    Percentage of participants who presented with arrest of dilation. Arrest of dilation was determined by the delivering physician.

    P-value was computed using Fisher exact test.


  • Failed Induction of Labor [ Time Frame: Until delivery ] [ Designated as safety issue: No ]

    Percentage of participants who were determined as a failed induction of labor. Failed induction was defined as no cervical change despite 24 hours of pitocin or 12 hours of pitocin after rupture of membranes.

    P value was computed by Fisher exact test.


  • Pitocin [ Time Frame: Until delivery ] [ Designated as safety issue: No ]
    Percentage of patients that used pitocin during labor. P-values were computed using Fisher exact test.

  • Foley Bulb [ Time Frame: Until delivery ] [ Designated as safety issue: No ]
    Percentage of participants that required foley bulb use.

  • Artificial Rupture of Membranes (AROM) [ Time Frame: Until delivery ] [ Designated as safety issue: No ]
    Percentage of participants that required AROM

  • Abnormal Fetal Heart Tracing (FHT) [ Time Frame: Until 4 hours of last misoprostol dose ] [ Designated as safety issue: Yes ]

    Feta heart tracing was reviewed for every participant until 4 hours from last misoprostol dose.

    Percentage of participants who presented with abnormal fetal heart tracing was computed.

    Abnormal fetal heart tracing was defined as category 2 and 3 fetal heart tracing according to standard criteria.

    Abnormal fetal heart tracing included any of the following tachycardia, bradycardia without absent variability, minimal variability, absent variability with or without recurrent decelerations, marked variability, prolonged deceleration and recurrent late deceleration, sinusoidal pattern.

    P values were computed by Fisher exact test.


  • Tachysystole With Abnormal FHT [ Time Frame: Until 4 hours after last misoprostol dose ] [ Designated as safety issue: Yes ]

    Feta heart tracing was reviewed for every participant until 4 hours from last misoprostol dose.

    Percentage of participants who presented with tachysystole and abnormal fetal heart tracing was computed.

    Abnormal fetal heart tracing was defined as category 2 and above. Tachysystole was defined as more than 5 uterine contractions within 10 minutes. P values were computed by Fisher exact test.


  • Tachysystole [ Time Frame: Until 4 hours after last misoprostol dose ] [ Designated as safety issue: Yes ]
    Fetal heart tracing was reviewed until 4 hours after last misoprostol dose. Percentage of participant with tachysystole were computed. Tachysystole was defined as more than five uterine contractions in 10 minutes. P value was computed using Fisher exact test

  • Neonatal Intensive Care Unit (NICU) Admission [ Time Frame: Until discharge from hospital ] [ Designated as safety issue: Yes ]

    Percentage of participants whose baby was admitted to NICU was computed from time to delivery to time of hospital discharge.

    P-value was computed using Fisher Exact test.


  • Meconium [ Time Frame: Until delivery ] [ Designated as safety issue: No ]
    Percentage of participants who developed meconium was computed. Presence of meconium was evaluated by the delivering physician. P-value was computed using Fisher exact test.

  • Chorioamnionitis [ Time Frame: Until 48 hours after delivery ] [ Designated as safety issue: Yes ]
    Percentage of participants affected with chorioamnionitis

  • APGARS [ Time Frame: 5 minutes after delivery ] [ Designated as safety issue: Yes ]

    Median (APGAR) score at 5 minutes after delivery. APGAR: Appearance, Pulse, Grimace, Activity, Respiration Apgar scale is determine by evaluating a newborn on 5 categories on a scale from 0 to 2, then summing up the five values.

    Score range is 0 to 10. Score above 7 are generally normal. Score below 3 may indicated poor status.


  • Patient Satisfaction With Buccal Versus Vaginal Misoprostol Administration. [ Time Frame: Until 72 hours after delivery ] [ Designated as safety issue: No ]

    All patients were given a patient satisfaction survey. Patients were asked to use a Likert scale to rate their experience on the following:

    Likert sub-scale: 1 to 5

    1=Not at all/ Never to 5= Very Much/ Always

    1. Nausea and vomiting 1=better outcome 5=worse outcome
    2. effectiveness of misoprostol 1=worse outcome 5=better outcome
    3. concerns of misoprostol 1=better outcome 5=worse outcome
    4. overall labor experience 1=worse outcome 5=better outcome Patients will be followed for the duration of their labor(usually up to 72hrs). The satisfaction survey will be conducted after delivery but will evaluate side effects that they recollect in labor.

  • Patient Preference [ Time Frame: Until 72 hours after delivery ] [ Designated as safety issue: No ]
    All patients were given a patient satisfaction survey after delivery. They were asked to select their preference for misoprostol intervention type: buccal, vaginal, or either.


Enrollment: 73
Study Start Date: July 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buccal misoprostol+placebo vaginal pill Drug: Buccal Misoprostol
Buccal rather than Vaginal misoprostol for induction of labor
Other Name: Cytotec
Active Comparator: Vaginal Misoprostol+placebo buccal pill Drug: Vaginal misoprostol
Vaginal rather than buccal misoprostol for induction of labor
Other Name: Cytotec

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willingness to participate / consent in a placebo-controlled trial
  • Age 18 and older
  • Pregnancy between 34 and 42 years of gestation
  • Admitted for labor induction because of either medical, obstetric, or psychosocial indications
  • Live singleton fetus
  • Bishop score less than or equal to six
  • Cephalic presentation
  • Reactive non-stress test or Negative contraction test

Exclusion Criteria:

  • Premature rupture of membranes
  • Multiparity > 5
  • Contraindication to vaginal or labor delivery
  • Suspected placental abruption
  • Significant hepatic, renal or cardiac disease
  • Known hypersensitivity to misoprostol or prostaglandin analogue
  • Recent prostaglandin administration for induction of labor
  • Multifetal pregnancy
  • Macrosomia > 4500g estimated fetal weight by ultrasound or leopold
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519765

Locations
United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Ram Parvataneni, MD Associate Clinical Professor
  More Information

Additional Information:
Responsible Party: Ram Parvataneni MD, MPH, Associate Clinical Professor of Obstetrics and Gynecology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01519765     History of Changes
Other Study ID Numbers: UCLA IRB#11-002056 
Study First Received: January 5, 2012
Results First Received: March 4, 2016
Last Updated: August 3, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 08, 2016