Intravaginal Isosorbide Mononitrate in Addition to Misoprostol Versus Misoprostol Only for Induction of Labor

August 6, 2018 updated by: Dina Yahia Mansour

Intravaginal Isosorbide Mononitrate in Addition to Misoprostol Versus Misoprostol Only for Induction of Labor: A Randomized Controlled Trial

Evaluation of safety & efficacy of nitric oxide donors such as intravaginal isosorbide mononitrate in addition to misoprostol Versus misoprostol only for the whole process of induction of labor.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • Type of Study: Randomised controlled clinical trial.
  • Study Setting: This study will be conducted at Ain Shams University's Emergency department of the Maternal Hospital.
  • Study Period: From January 2018 to June 2018 (6 months)
  • Randomization: Will be done using computer generated randomization sheet using MedCalc© version 13. ( Appendix 1)
  • Allocation and concealment: Fifty opaque envelops will be numbered serially and in each envelope the corresponding letter which denotes the allocated group will be put according to randomization table. Then all envelopes will be closed and put in one box. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside.

  • Study Population: Fifty pregnant women.

    • Inclusion Criteria:

      • Primigravida.
      • From 20 to 30 years old.
      • Singleton term (between 40 to 42 weeks of gestation).
      • Good general condition with straightforward enthusiasm for the trial.

    • Exclusion Criteria:

      • IUGR.
      • Rupture of membranes.
      • Favorable cervix (Bishop score : '8' or more)
      • Cephalopelvic disproportion,fetal malpresentation.
      • Antepartum hemorrhage, any abnormal placentation such as placenta previa, morbidly adherent placenta.
      • Uterine fibroid.
      • Previous uterine major surgery such as : myomectomy.
      • Any medical disorder such as : gestational diabetes, diabetes mellitus, hypertension, preeclampsia, coagulation disorders, renal and hepatic dysfunction.
  • Sampling Method: Convenience sampling.
  • Sample Size: Fifty women.
  • Sample Justification: Using data from previous study by Abdellah et al. 2010, which compared isosorbide mononitrate and misoprostol versus misprostol only. Misoprostol only group induction to delivery interval was 23 hours while in the isosorbide mononitrate and misorprostol group it was 19.6 hours. We will use sample size of 25 women in each of the two groups to achieve 91% power to detect statistical difference of atleast 3.4 hours. With estimated group standard deviations of 4.0 and 2.6 and with a significance level (alpha) of 0.05 using Mann-Whitney test; the sample size of 50 women as stated before is satisfactory to detect difference between initial dose to delivery.
  • Ethical Considerations: An informed consent will be taken from all participants, it will be in Arabic language and confirmed by date & time. No harm will be inflicted & no benefit will be deprived in this study.

  • Study Procedures:

    • Fifty Primigravida women will be recruited according to inclusion and exclusion criteria.
    • History taking.
    • Physical examination.
    • Ultrasound: for placental localization excluding abnormal localization, exclude Fetal IUGR, oligohydraminos, polyhydraminos, fibroids.
    • Laboratory investigations: CBC (complete blood count) , Coagulation Profile, Liver function test, Kidney function test, ABO Rhesus D (RhD).
    • Counseling of the patient about isosorbide mononitrate and misoprostol.
    • Recruited patients will fill a written consent.
    • Two types of envelopes will be available, one with misoprostol & placebo, other will contain misoprostol & isosorbide mononitrate which will be given by vaginal route.
    • Patient will choose an envelope from the previous 2 types.
    • 2 groups will be formed; group 1 will take both misoprostol & isosorbide mononitrate, group 2 will take Misoprostol only. Group 1 will take intial dose of 40mg isosorbide mononitrate (Mono-Mak) in the posterior vaginal fornix which will not be repeated; followed by intravaginal 25mcg of misoprostol (Vagiprost), misoprostol will be repeated every 6 hours for maximum of 5 doses (i.e. 125mcg), (FIGO recommendation for misoprostol regimen 2017 & WHO recommendations for induction of labour 2011). Misoprostol will be stopped when labour is established defined by 3 contractions every 10 minuites, each contraction of 30 seconds duration, with amplitude of 40 mmHg or if 6 hours passed after the last misoprostol dose and labour is not established as defined before with unfavorable cervix defined by bishop score of 6 or less, cesarean delivery will be performed. Group 2 will take only misoprostol with same scheme for misoprostol as before in group 1.

    • Induction of labor process will take place, during which:

      • Maternal blood pressure & pulse will be assessed every 30 minutes for the first 2 hours then hourly after that; temperature will be assessed every 4 hours.
      • Fetal auscultation will be carried out every 15 minutes in 1st stage of labor, every 5 minutes in 2nd stage of labor after uterine contraction for at least 1 minuite.
      • CTG will be performed every 2 hours or if there are concerns during fetal ausculatation. Continuous CTG maybe continued upon maternal request or if there are high risk factors such as contractions that last longer than 60 seconds(hypertonus) or more than 5 contractions in 10 minutes(tachysystole), Oxytocin use.

  • Study Interventions: Cesarean Delivery will be performed in the following circumstances:

    • if Induction of labor failure is established defined by unfavorable cervix after 6 hours from the last dose of 5 doses of Misoprostol each is 25 mcg (maximum dose of 125mcg)
    • If management of protraction & arrest disorders failed.
    • If CTG monitoring was classified as pathological and conservative management failed; or if CTG monitoring warned the need for urgent intervention.
  • Statistical Analysis: Descriptive statistics for measured variables will be expressed as range mean and standard deviation (for metric data); range, median and interquartile range (for discrete data); and number and proportion (for categorical data). Demographic data and primary and secondary outcomes of all women will be compared using t-test (for quantitative parametric measures), Mann-Whitney's U-test (for quantitative non-parametric measures) and chi squared and Fisher's Exact tests (for categorical measures). Pearson's correlation coefficient (for metric variables) and Spearman's correlation coefficient (for rank variables) will be used to estimate association between variables.
  • Statistical Package: Data will be collected, edited and entered into suitable software for data entry & analysis such as 'SPSS version 20'.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Department of Obs & Gyn,Faculty of Medicine, Ain shams University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primigravida.
  • From 20 to 30 years old.
  • Singleton term (between 40 to 42 weeks of gestation).
  • Good general condition with straightforward enthusiasm for the trial.

Exclusion Criteria:

  • IUGR.
  • Rupture of membranes.
  • Favorable cervix (Bishop score : '8' or more)
  • Cephalopelvic disproportion,fetal malpresentation.
  • Antepartum hemorrhage, any abnormal placentation such as placenta previa, accreta, increta and percreta
  • Uterine fibroid.
  • Previous uterine major surgery such as : myomectomy, uterine repair caused by trauma and metroplasty for Mullerian anomalies.
  • Any medical disorder such as : gestational diabetes, diabetes mellitus, hypertension, preeclampsia, renal & hepatic dysfunction, coagulation disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Misoprostol only
This group will receive Intravaginal Misoprostol only.
Drug: Isosorbide Mononitrate 40 MG to study group
Isosorbide Mononitrate will be added to Misoprostol, to determine their combined effect on cervical ripening & induction of labor in study group
Other Names:
  • Misoprostol 25Mcg
OTHER: Isosorbide Mononitrate & Misoprostol
This group will reveive intravaginal Isosorbide Mononitrate & Misoprostol.
Drug: Isosorbide Mononitrate 40 MG to study group
Isosorbide Mononitrate will be added to Misoprostol, to determine their combined effect on cervical ripening & induction of labor in study group
Other Names:
  • Misoprostol 25Mcg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Decrease interval between drug use to delivery
Time Frame: 6 months
Adding Isosorbide Mononitrate to Misoprostol will decrease time required for induction of labor.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dina Yahia Mansour

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hesham M. Harb, MD, Professor of Obstetrics & Gynecology
  • Principal Investigator: Dina Y. Mansour, MD, Lecturer Of obstetrics & Gynecology
  • Principal Investigator: Yahia M. A. Mohamed ELBoukhary A.A., M.B.B.Ch, Msc Student, Resident of Obstetrics & Gynecology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Vaginal nitric oxide donor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We will see if the study may add new to the scientific society or no, if the study is done, completed in a good environment and we are convinced that it may provide new information to others, we will share it.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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