Induction of LaborPhase 1/2NCT03523754

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

A Phase 1/2 study testing Isosorbide Mononitrate 40 MG to study group in people with Induction of Labor, run by Dina Yahia Mansour at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Induction of Labor
What is being tested?: Isosorbide Mononitrate 40 MG to study group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteEgypt
Study dates: 1 Jan 2018to 30 Nov 2018
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

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

Other trials in Egypt

About this study

Official title: 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.

Read the 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'.

Conditions: Induction of Labor
Being tested: Isosorbide Mononitrate 40 MG to study group
Keywords: Induction of labor, isosorbide mononitrate, misoprostol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Isosorbide Mononitrate 40 MG to study groupDrug
Also called Misoprostol 25Mcg
Isosorbide Mononitrate will be added to Misoprostol, to determine their combined effect on cervical ripening \& induction of labor in study group

Study groups in NCT03523754
Study group	Role	What they receive
Misoprostol only	Other	This group will receive Intravaginal Misoprostol only. Receives: Drug: Isosorbide Mononitrate 40 MG to study group
Isosorbide Mononitrate & Misoprostol	Other	This group will reveive intravaginal Isosorbide Mononitrate \& Misoprostol. Receives: Drug: Isosorbide Mononitrate 40 MG to study group

What is being measured

The primary outcome is the main question the study is designed to answer.

Decrease interval between drug use to delivery
Adding Isosorbide Mononitrate to Misoprostol will decrease time required for induction of labor.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201830 Nov 2018

First posted14 May 2018
Study start1 Jan 2018
Primary completion1 Oct 2018 (estimated)
Study completion30 Nov 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Induction of LaborStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: * 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.
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03523754
Sponsor's protocol ID: Vaginal nitric oxide donor
Status last verified: Aug 2018
First submitted: 13 Feb 2018
Last updated: 7 Aug 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety

All Induction of Labor trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravaginal Isosorbide Mononitrate in Addition to Misoprostol Versus Misoprostol Only for Induction of Labor: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03523754
Acronym / sponsor ID: Vaginal nitric oxide donor
Conditions: Induction of Labor
Keywords: Induction of labor, isosorbide mononitrate, misoprostol
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Dina Yahia MansourUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 1 Oct 2018 (estimated)
Study completion: 30 Nov 2018 (estimated)
First posted: 14 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: * 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.

Arm	Type	Receives
Misoprostol only	Other	Drug: Isosorbide Mononitrate 40 MG to study groupThis group will receive Intravaginal Misoprostol only.
Isosorbide Mononitrate & Misoprostol	Other	Drug: Isosorbide Mononitrate 40 MG to study groupThis group will reveive intravaginal Isosorbide Mononitrate \& Misoprostol.

Who may qualify

Ages: 20 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Isosorbide Mononitrate 40 MG to study groupAlso: Misoprostol 25McgIsosorbide Mononitrate will be added to Misoprostol, to determine their combined effect on cervical ripening \& induction of labor in study group	Drug	Isosorbide Mononitrate & Misoprostol, Misoprostol only

Primary outcome

Decrease interval between drug use to delivery
Time frame: 6 months
Adding Isosorbide Mononitrate to Misoprostol will decrease time required for induction of labor.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Individual participant dataSharing planned: Undecided. 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.

Related trials for Induction of Labor

Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hesham M. Harb, MD principal investigator

Professor of Obstetrics & Gynecology

Dina Y. Mansour, MD principal investigator

Lecturer of Obstetrics & Gynecology

Yahia M. A. Mohamed ELBoukhary A.A., M.B.B.Ch principal investigator

Msc Student, Resident of Obstetrics & Gynecology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Isosorbide Mononitrate 40 MG to study group in people with Induction of Labor, run by Dina Yahia Mansour at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease interval between drug use to delivery (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03523754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.