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Oral Misoprostol Solution in Labor Induction

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: NCT03927807
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Esam salah mohamed hagag, Ain Shams University

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 Intervention/treatment Phase
Labour,Induced Drug: Misoprostol 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.

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Study Type : Interventional  (Clinical Trial)
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 18, 2019
Estimated Primary Completion Date : December 18, 2019
Estimated Study Completion Date : January 18, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

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.





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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   150 pregnant women who fulfill inclusion criteria.these will be subjected to history taking,physical examination,counseling and signing a written consent will be taken from each case.
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

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): NCT03927807


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

Locations
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Egypt
Ain Shams University Recruiting
Cairo, Cairo Governorate, Egypt, 002
Contact: esam sa hagag, MBBCh    01066813830    essamhagag742@yahoo.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: essam sa hagag, MBBCh Ain Shams University
Publications of Results:
27986461

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Responsible Party: Esam salah mohamed hagag, Director,clinical research, Ain Shams University
ClinicalTrials.gov Identifier: NCT03927807    
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Esam salah mohamed hagag, Ain Shams University:
misoprostol
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