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A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02777190
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : May 26, 2021
Sponsor:
Information provided by (Responsible Party):
Jaimey M. Pauli, MD, Milton S. Hershey Medical Center

Brief Summary:
The purpose of this study is to study if misoprostol administered orally is at least as effective as misoprostol administered vaginally for cervical ripening and the induction of labor. The main purpose is to show that oral misoprostol administration is non-inferior to vaginal misoprostol administration with respect to the time interval from misoprostol administration to onset of active phase of labor. The study is a non-inferiority, prospective randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus vaginal misoprostol given as 25 mcg every 4 hours.

Condition or disease Intervention/treatment Phase
Labor; Forced or Induced, Affecting Fetus or Newborn Pregnancy Drug: Misoprostol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: Oral misoprostol
oral misoprostol given 25 mcg every 2 hours
Drug: Misoprostol
Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.
Other Name: Cytotec

Active Comparator: Vaginal misoprostol
vaginal misoprostol given 25 mcg every 4 hours
Drug: Misoprostol
Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.
Other Name: Cytotec




Primary Outcome Measures :
  1. Time interval from start of induction of labor (first misoprostol administration) to active phase of labor (greater than or equal to 6 cm cervical dilation). [ Time Frame: 12-24 hours ]

Secondary Outcome Measures :
  1. time interval from start of induction of labor to initiation of oxytocin for augmentation [ Time Frame: 12 hours ]
  2. time interval from start of induction of labor to vaginal delivery [ Time Frame: 24 hours ]
  3. cesarean section rate [ Time Frame: 1-2 days ]
  4. rate of tachysystole [ Time Frame: 1-2 days ]
  5. rate of tachysystole causing non-reassuring fetal heart tones [ Time Frame: 1-2 days ]
  6. rate of need for tocolysis [ Time Frame: 1-2 days ]
  7. rate of chorioamnionitis [ Time Frame: 1-2 days ]
  8. rate of meconium stained fluid [ Time Frame: 1-2 days ]
  9. neonatal morbidity [ Time Frame: 1-2 days ]
    composite outcome of Apgar score, cord gases, neonatal intensive care unit admission, and/or neonatal death

  10. rate of anti-emetic use [ Time Frame: 1-2 days ]
    maternal side effect

  11. rate of diarrhea [ Time Frame: 1-2 days ]
    maternal side effect

  12. rate of vaginal delivery within 24 hours [ Time Frame: 24 hours ]
  13. rate of abandoning misoprostol for cervical ripening and switching to mechanical dilation for cervical ripening [ Time Frame: 24 hours ]
  14. rate of development of preeclampsia requiring magnesium sulfate administration [ Time Frame: 12-24 hours ]
  15. treatment emergent serious adverse events [ Time Frame: 0-28 days ]
    uterine rupture, cesarean hysterectomy, maternal death during hospitalization, neonatal death (0-28 days of life) related to the study drug

  16. adverse events [ Time Frame: 1-2 days ]
    postpartum hemorrhage requiring blood transfusion, maternal surgical ICU admission, neonatal NICU admission during mother's hospital admission



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Pregnant Female Patients greater than or equal to 18 years of age
  2. Induction of labor for a single live intrauterine pregnancy
  3. Greater than or equal to 37 weeks gestational age
  4. Cephalic presentation
  5. 20 minute reassuring fetal heart rate (reactive nonstress test (NST))
  6. Bishop score based on sterile vaginal exam of less than or equal to 6, for which the cervical dilation is less than or equal to 2 cm.
  7. Equal to 3 or less uterine contractions over 10 minutes

Exclusion Criteria:

  1. Previous uterine scar
  2. Contraindication to vaginal delivery
  3. Patients with preeclampsia
  4. Grand multiparty - greater than or equal to 5 live births or stillbirths
  5. Premature rupture of membranes
  6. Suspected intrauterine growth restriction
  7. Fetal anomalies
  8. Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)

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): NCT02777190


Contacts
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Contact: Jaimey Pauli, MD 7175313503 jpauli@pennstatehealth.psu.edu
Contact: Sandra Eyer 717-531-6208 seyer@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Jaimey Pauli, MD    717-531-8142 ext 5    jpauli@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Jaimey Pauli, MD Milton S. Hershey Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaimey M. Pauli, MD, Principal Investigator, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02777190    
Other Study ID Numbers: 00005107
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: May 2021
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: No
Keywords provided by Jaimey M. Pauli, MD, Milton S. Hershey Medical Center:
misoprostol
cytotec
cervical ripening
labor, induced
active labor
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics