Cervical Ripening and Induction of Labor
Conditions
Brief summary
The goal of this clinical trial is to study the efficacy of vaginal versus oral misoprostol solution in cervical ripening for induction of labor. The main questions it aims to answer is : is Vaginal misoprostol solution as effective as oral misoprostol solution for induction of labor? Researchers will compare oral Misoprostol Solution and vaginal misoprostol solution prepared by KY gel Participants will then be randomized into two groups using a computer-generated randomization list , the first group will receive oral solution equal to 25 microgram misoprostol every 2 hours while the second group will receive 25 microgram vaginal misoprostol solution every 4 hours The cervix will be assessed and scored at each examination. They will be reviewed before the stipulated time if they were contracting. The administration of the drugs will be discontinued when a favorable cervix is diagnosed (modified Bishop score ≥6 ) or 24 hours of study drug had been given.
Interventions
DRUGVaginal misoprostol
the vaginal misoprostol solution will be prepared by complete crushing of one misoprostol 200 µg tablet into powder then adding the powder into a clean urine specimen cup then adding 20 cc of KY gel measured by a 20 ml syringe then mix the contents together to ensure adequate distribution of the powder , each patient will receive only 2.5cc of the mixture vaginally (inserted into the posterior fornix,) by using medical 3ml syringes equal to 25 mcg misoprostol 4 hourly according to International Federation of Gynecology and Obstetrics (FIGO2023) and remain recumbent for 10-20 minutes
the solution will be prepared by dissolving one 200 µg tablet in 200 ml of tap water , each member will receive 25 cc misoprostol solution equal to 25 mcg misoprostol 2 hourly according to International Federation of Gynecology and Obstetrics (FIGO2023)
Sponsors
Hagar Muhammad Abdulfattah Muhammad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women with a singleton pregnancy. 2. Cephalic presentation. 3. Age range: 18-40 years. 4. Gestational age between 36 and 42 weeks. 5. Intact fetal membranes. 6. Absence of spontaneous uterine contractions. 7. Non favorable cervix (Bishop score ≤ 5). 8. A reactive non stress test in case of positive fetal life.
Exclusion criteria
1. History of cesarean section or uterine scars 2. Grand Multipara P ≥5 3. Known fetal non-cephalic presentation 4. Any known allergy to misoprostol. 5. Multiple pregnancy 6. Contraindication to vaginal delivery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is induction to cervical ripening (Bishop score ≥6) time interval. | 24 hours max |
Countries
Egypt
Outcome results
None listed