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Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor
The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (ISMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor.
Research Hypothesis:
In women undergoing induction of labor, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery.
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Research Questions:
Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor?
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Induction of Labor Affected Fetus / Newborn | Drug: isosorbide mononitrate Drug: Placebos | Phase 3 |
Patient and methods
Type of study:
Prospective double blinded randomized placebo-controlled clinical trial.
Study setting:
The study will be conducted at Cairo university in labor ward of Kasr El Ainy Hospital.
Study period:
approximately 6 months from June 2018 to December 2018.
Study population:
Patients will be recruited in this study those attending labor ward at kasr el ainy hospital for induction of labor after 39 weeks of gestation.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 140 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | The patients will be divided into 2 groups Group 1: 70 women: patients were induced by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM) Group 2: 70 patients induced by placebo (pyridoxine) administered in the posterior vaginal fornix. |
| Masking: | Single (Participant) |
| Masking Description: | To insure that everyone has the chance of participation, Randomization will be done using computer generated randomization sheet using statsdirect version 3. Double blinding will be done by one of the supervisors who will be the only one to know the key, thus the care provider and the patient will not know is it the drug or the placebo. |
| Primary Purpose: | Supportive Care |
| Official Title: | Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor |
| Actual Study Start Date : | May 1, 2018 |
| Actual Primary Completion Date : | August 30, 2020 |
| Actual Study Completion Date : | October 15, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: isosorbide mononitrate group
isosorbide mononitrate group (study group) 70 patients are induced by Intra vaginal isosorbide mono nitrate at 36, 24 , 12 before induction
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Drug: isosorbide mononitrate
isosorbide mononitrate group (study group) 70 patients are induced by Intra vaginal isosorbide mono nitrate at 36, 24 , 12 before induction
Other Name: Effox 40 mg
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Placebo Comparator: placebos group
70 patients induced by placebo (pyridoxine) placebo tablet of the same size and shape as the isosorbide mononitrate. administered in the posterior vaginal fornix at 36, 24 , 12 before induction
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Drug: Placebos
70 patients induced by placebo (pyridoxine) administered in the posterior vaginal fornix.
Other Name: pyridoxine
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- admission-delivery interval [ Time Frame: up to 24 hours ]The time from initiation of cervical ripening till delivery of placenta
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Bishop score < or = 6
- Singleton pregnancy
- 39 or more completed weeks of gestation
- Cephalic presentation
- Average size of the fetus, and absence of pelvic contraction
Exclusion Criteria:
-
any contraindication of labor induction listed in the American College of Obstetrics and Gynecology
- Previous classical or inverted T-shaped or unknown uterine incision
- Previous hysterotomy/ myomectomy of the uterine corpus involving entry of the uterine cavity or extensive myometrial dissection
- Previous uterine rupture
- Placenta previa or Vasa previa
- Abnormal fetal lie
- Active genital herpes infection
- Major degree of cephalopelvic disproportion and contracted pelvis
- Grand multipara
- Malpresentation
- Over distension of uterus like polyhydramnios or multiple pregnancy
- Invasive carcinoma cervix
- Pregnancy following repair for vesicovaginal fistula
- Prelabour rupture of membranes
- Previous Lower segment cesarean section.
- Umbilical cord prolapse.
- Established fetal distress
- Heart disease complicating Pregnancy
- Liver disease complicating Pregnancy
- Anemia complicating Pregnancy
| Egypt | |
| faculty of medicine - Cairo university | |
| Cairo, Kasr El Ainy, Egypt, 11562 | |
| Principal Investigator: | waleed M el khyat, MD | Cairo University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 18, 2018 | ||||
| First Posted Date ICMJE | June 4, 2018 | ||||
| Last Update Posted Date | November 16, 2020 | ||||
| Actual Study Start Date ICMJE | May 1, 2018 | ||||
| Actual Primary Completion Date | August 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
admission-delivery interval [ Time Frame: up to 24 hours ] The time from initiation of cervical ripening till delivery of placenta
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| Original Primary Outcome Measures ICMJE |
admission-delivery interval [ Time Frame: time from induction of labor to delivery of placenta ] The time from initiation of cervical ripening till delivery
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor | ||||
| Official Title ICMJE | Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor | ||||
| Brief Summary |
The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (ISMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor. Research Hypothesis: In women undergoing induction of labor, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery. . Research Questions: Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor? |
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| Detailed Description |
Patient and methods Type of study: Prospective double blinded randomized placebo-controlled clinical trial. Study setting: The study will be conducted at Cairo university in labor ward of Kasr El Ainy Hospital. Study period: approximately 6 months from June 2018 to December 2018. Study population: Patients will be recruited in this study those attending labor ward at kasr el ainy hospital for induction of labor after 39 weeks of gestation. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: The patients will be divided into 2 groups Group 1: 70 women: patients were induced by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM) Group 2: 70 patients induced by placebo (pyridoxine) administered in the posterior vaginal fornix. Masking: Single (Participant)Masking Description: To insure that everyone has the chance of participation, Randomization will be done using computer generated randomization sheet using statsdirect version 3. Double blinding will be done by one of the supervisors who will be the only one to know the key, thus the care provider and the patient will not know is it the drug or the placebo. Primary Purpose: Supportive Care
|
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| Condition ICMJE | Induction of Labor Affected Fetus / Newborn | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
140 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | October 15, 2020 | ||||
| Actual Primary Completion Date | August 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Egypt | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03544606 | ||||
| Other Study ID Numbers ICMJE | ISMN and labor induction | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | ahmed nagy shaker ramadan, Cairo University | ||||
| Study Sponsor ICMJE | ahmed nagy shaker ramadan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Cairo University | ||||
| Verification Date | November 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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