Clinical trial NCT04891679: Induction of Labor by Oral Misoprostol Solution
Official title: A Randomised Control Study of Titrated and Static Oral Misoprostol for Induction of Labor at Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labor
Lead sponsor: Christian Medical College and Hospital, Ludhiana, India
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center interventional single-blinded randomised controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Singleton live pregnancy;
2. ≥37 weeks gestation;
3. Cephalic presentation;
4. Reassuring fetal heart rate;
5. Modified Bishop'score

Exclusion Criteria:

1. Hypersensitivity to misoprostol;
2. Uterine scar due to previous cesarean section or other uterine surgery;
3. Grand multipara;
4. Multiple gestations;
5. High risk pregnanacies • preeeclampsia with severe features • significant maternal cardiac,renal, liver disease
6. Any contraindication to induction and vaginal delivery e.g. cephalopelvic disproportion, malpresentation, fetal compromise and ante partum hemorrhage
7. Intrauterine fetal demise

Primary outcomes:
measure: Interval between induction and delivery
timeFrame: From first dose of oral misoprostol solution (titrated/static) to childbirth; upto 5 days
Secondary outcomes:
measure: Mean change in modified Bishop's score
timeFrame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
measure: Number of misoprostol doses
timeFrame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
measure: Time taken to give required doses
timeFrame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
measure: Total misoprostol dosage
timeFrame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
measure: Mode of delivery
timeFrame: Upto 5 days from first dose of oral misoprostol solution
measure: Indication for LSCS
timeFrame: Upto 5 days from first dose of oral misoprostol solution
measure: Oxytocin augmentation
timeFrame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
measure: Maternal morbidity
timeFrame: From first dose of oral misoprostol solution to dischage from hospital; upto 7 days
measure: Neonatal parameters
timeFrame: From childbirth to discharge of the baby; upto 1 month
Other outcomes:
Locations:
city: Ludhiana
country: India
facility: Christian Medical College and Hospital
state: Punjab
Study officials:
affiliation: Department of obstetrics and gynecology, Christian Medical College and hospital, Ludhiana
name: SUNITA GOYAL, MBBS, MD
role: STUDY_CHAIR
References:
citation: Rouzi AA, Alsahly N, Alamoudi R, Almansouri N, Alsinani N, Alkafy S, Rozzah R, Abduljabbar H. Randomized clinical trial between hourly titrated and 2 hourly static oral misoprostol solution for induction of labor. Am J Obstet Gynecol. 2017 Apr;216(4):405.e1-405.e6. doi: 10.1016/j.ajog.2016.11.1054. Epub 2016 Dec 14.
citation: Aduloju OP, Ipinnimo OM, Aduloju T. Oral misoprostol for induction of labor at term: a randomized controlled trial of hourly titrated and 2 hourly static oral misoprostol solution. J Matern Fetal Neonatal Med. 2021 Feb;34(4):493-499. doi: 10.1080/14767058.2019.1610378. Epub 2019 Apr 29.