Induction of Labor by Oral Misoprostol Solution
- Conditions
- Induction of Labor
- Interventions
- Drug: Oral misoprostol solution (OMS)
- Registration Number
- NCT04891679
- Lead Sponsor
- Christian Medical College and Hospital, Ludhiana, India
- Brief Summary
AIM: To evaluate effectiveness and safety of titrated oral misoprostol solution (OMS) in comparison with static-dose oral misoprostol solution for induction of labor at term.
Women with singleton live pregnancy at term without any complications who were admitted in labor room for induction of labor were enrolled.
Study involves allocation of selected women in two groups randomly and use of either titrated or static oral misoprostol dose regimen to induce labor. Possible benefits included rapid induction of labor with oral drug regimen which is easier to comply as compared to vaginal regimens. Women were at risk of all the complications associated with induction of labor like labor abnormalities, risk of cesarean section, non reassuring fetal status.
- Detailed Description
This comparative randomized study was conducted in the Department of Obstetrics and Gynecology, Christian medical college and hospital, Ludhiana for a period of one year beginning from 1st December, 2017 to 30th November, 2018. The study group comprised of all antenatal women admitted in labor room at term for induction of labor. Informed consent was taken for all selected women. Women were subjected to detailed history taking, a complete physical examination including per vaginum examination (to calculate modified bishop's score and to rule out cephalopelvic disproportion), investigations and a NST. Gestational age was established by the first date of the last menstrual period and confirmed by first trimester ultrasound. Presentation was confirmed by palpation and third trimester ultrasound.
Women after randomization were allocated into two groups. The first group (A) was induced with hourly titrated oral misoprostol regimen and the second group (B) received two hourly static oral misoprostol regimen. Once labor had started, vital signs were closely monitored every 2 hours; fetal heart rate (FHR) and uterine activity every 15 minutes during first stage of labor. Per vaginum examination was done 4-hourly or as indicated.
Primary and secondary outcome measures were noted and analyzed to compare safety and efficacy of titrated and oral misoprstol solution.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 264
- Singleton live pregnancy;
- ≥37 weeks gestation;
- Cephalic presentation;
- Reassuring fetal heart rate;
- Modified Bishop'score
- Hypersensitivity to misoprostol;
- Uterine scar due to previous cesarean section or other uterine surgery;
- Grand multipara;
- Multiple gestations;
- High risk pregnanacies • preeeclampsia with severe features • significant maternal cardiac,renal, liver disease
- Any contraindication to induction and vaginal delivery e.g. cephalopelvic disproportion, malpresentation, fetal compromise and ante partum hemorrhage
- Intrauterine fetal demise
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A (Titrated OMS) Oral misoprostol solution (OMS) Titrated oral misoprostol solution Group B (Static OMS) Oral misoprostol solution (OMS) Static oral misoprostol solution
- Primary Outcome Measures
Name Time Method Interval between induction and delivery From first dose of oral misoprostol solution (titrated/static) to childbirth; upto 5 days The time taken from induction of labor to delivery measured as
1) \<12 hours 2) 12-24 hours 3) 24-48 hours 4) \>48 hours
- Secondary Outcome Measures
Name Time Method Number of misoprostol doses From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days Measured as 1-2; 3-4; 5-6; 7-8; \>9
Mean change in modified Bishop's score From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days Measured as difference between modified bishop's score before induction of labor and at amniotomy/stopping of oral misoprostol solution regimen; minimum 0f 1 to maximum of 7.
Total misoprostol dosage From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days Measured as \</=75mcg; 76-150mcg; 151-225mcg; 226-300mcg; \>301 mcg
Oxytocin augmentation From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days Required/Not required
Time taken to give required doses From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days Measured as 1-4 hours; 5-8 hours; 9-12 hours; 13-16 hours; 17-20 hours; 21-24 hours
Mode of delivery Upto 5 days from first dose of oral misoprostol solution In terms of Vaginal delivery/LSCS
Indication for LSCS Upto 5 days from first dose of oral misoprostol solution Divided into either of the following:
1. SECONDARY ARREST OF DILATATION
2. MSAF IN EARLY LABOR
3. CTG CATEGORY III
4. FAILED INDUCTION
5. CEPHALOPELVIC DISPROPORTION
6. CORD PROLAPSE
7. DEEP TRANSVERSE ARREST
8. ARREST OF DESCENT OF HEADMaternal morbidity From first dose of oral misoprostol solution to dischage from hospital; upto 7 days In terms of incidence of either of the following:
1. Incidence of tachysystole
2. Fever- intrapartum and postpartum
3. Puerperal sepsis
4. Uterine ruptureNeonatal parameters From childbirth to discharge of the baby; upto 1 month Measured in terms of incidence of either of the following:
1. Incidence of meconium-stained liquor
2. APGAR scores at 1,5 min
3. NICU stay
Trial Locations
- Locations (1)
Christian Medical College and Hospital
🇮🇳Ludhiana, Punjab, India