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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Oral Misoprostol Solution in Labor Induction

Clinicaltrials.gov identifier NCT03927807

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted April 25, 2019

Study Description

Brief summary:

This study compares safety and efficacy between repetitive hourly dose of oral misoprostol and two hourly dose oral regimens for cervical ripening and labor induction.

  • Condition or Disease:Labour,Induced
  • Intervention/Treatment: Drug: Misoprostol
  • Phase: Phase 2
Detailed Description

Misoprostol is an effective agent for the induction of labor.existing guidelines recommend oral misoprostol solution every two hours.However,more research is required to optimize the use of oral misoprostol solution for labor induction.The current study is to compare efficacy and safety of repetitive hourly dose of oral misoprostol solution with two hourly dose of oral misoprostol solution for cervical ripening and labor induction.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 150 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Comparison of the Efficacy and Safety of Repetitive Hourly Dose of Oral Misoprostol and Two Hourly Dose Oral Regimens for Cervical Ripening and Labor Induction
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: January 2020
Arms and interventions
Arm Intervention/treatment
Experimental: repetitive hourly dose of oral misoprostol
The dose will be 10 microgram oral misoprostol that will be administered hourly up to 12 doses or till onset of regular uterine activity.
Drug: Misoprostol
This study will include 150 pregnant women who fulfill the inclusion criteria and will be subdivided in two groups. Group1 will receive repetitive hourly dose of oral misoprostol solution equal to 10 microgram up to 12 doses or regular uterine activity. Group2 will receive oral misoprostol solution every two hours as 20 microgram up to 6 doses or regular uterine activity.
Experimental: two hourly dose of oral misoprostol
The dose will be 20 microgram oral misoprostol solution that will be administered every 2 hours up to 6 doses or till onset of regular uterine activity.
Drug: Misoprostol
This study will include 150 pregnant women who fulfill the inclusion criteria and will be subdivided in two groups. Group1 will receive repetitive hourly dose of oral misoprostol solution equal to 10 microgram up to 12 doses or regular uterine activity. Group2 will receive oral misoprostol solution every two hours as 20 microgram up to 6 doses or regular uterine activity.
Outcome Measures
  • Primary Outcome Measures: 1. Mode of delivery [ Time Frame: 24 hours from the first dose of induction till delivery ]
    Successful vaginal delivery within 24 hours from starting induction of labor or cesarean section delivery after failed trial of induction.
  • Secondary Outcome Measures: 1. Adverse maternal outcomes [ Time Frame: in 24 hours ]
    As uterine hyper stimulation,fever,vomiting,shivering,nausea
  • 2. Adverse neonatal outcomes [ Time Frame: 24 hours post partum ]
    As neonatal intensive care unit admission,non reassuring fetal heart rate
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Nulliparas

- Term pregnancy(equal or more than 37 wks)

- Bishop score <6 - Cephalic presentation - reassuring fetal heart rate pattern - Not in labor ( no uterine contractions) - Clinically adequate pelvis - Singleton live pregnancy Exclusion Criteria: - Allergic to misoprostol or prostaglandin analogues - Previous uterine scar( cesarean section,hysterotomy,myomectomy) - Multiple fetal gestations - Fetal demise - Preterm labor - Malpresentations - Non reactive cardiotocography at admission - Cephalo pelvic disproportion - Fetal macrosomia

Contacts and Locations
Contacts

Contact: essam sa hagag, MBBCh 01066813830 essamhagag742@yahoo.com

Locations

Egypt, Cairo Governorate
Ain Shams University
Cairo

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: essam sa hagag, MBBCh Ain Shams University

More Information
  • Publications of Results

    27986461

  • Responsible Party: Ain Shams University
  • ClinicalTrials.gov Identifier: NCT03927807 History of Changes
  • Other Study ID Numbers: misoprostol in induction
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: April 25, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be available.
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: Data will be available within 6 months of study completion.
  • Access Criteria: Data access requests will be reviewed by an external independent review panel.requestors will be required to sign a data access agreement.
  • URL: http://bethesda.org
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Ain Shams University: misoprostol