Induction of Labor Affected Fetus / Newborn
Conditions
Brief summary
The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) 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?
Detailed description
* Type of Study : Prospective double blind randomized controlled clinical trial. * Study Setting : This study will be conducted in Kafr Elsheikh University maternity hospital. * Study Period : Expected 6 months from December 2023 to June 2024. * Study Population : Patients will be recruited in this study those attending labor ward at Kafr Elsheikh hospital for induction of labor at term or post-term with unripe cervix (Bishop Score ˂ 6).
Interventions
40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses.
DRUGPlacebos
In placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given
Sponsors
Kafrelsheikh University
ahmed nagy shaker ramadan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
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.
Intervention model description
The patients will be divided into 2 groups. Group 1: 80 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM) Group 2: 80 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Singleton pregnancy. * Cephalic presentation. * Bishop score \< 6. * Average size of the fetus. * Adequate pelvic dimensions. * Term or post-term pregnancies with an indication for labor induction either maternal or fetal.
Exclusion criteria
* • Previous uterine scar. * Patients with regular uterine contractions. * Malpresentation. * Multifetal gestation. * Prelabour rupture of membranes. * Established fetal distress. * Indication for CS, e.g. Major degree of cephalopelvic disproportion and fetal macrosomia. * Antepartum hemorrhage. * Active genital herpes infection. * Severe maternal illness (e.g. severe preeclampsia).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| admission-delivery interval | up to 24 hours | The time from initiation labor induction and delivery of placenta |
Countries
Egypt
Outcome results
None listed