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.

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.

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

Pregnant females were enrolled for induction of labor in the study.

IPD that underlie the results reported in the study, after deidentification (text, tables, figures and appendices) will be shared in the excel sheet format.

Data will be available beginning immediately and ending 36 months following article publication.

Anyone who wishes to access the data for any purpose. Link will be made available at a later date.

Women were randomized (1:1) into the treatment groups A) Titrated-dose OMS group B) Static dose OMS group; using computer generated number sequence. Allocation concealment was carried out by using opaque envelopes that were distributed by the obstetrics nurse. Whereas study investigators and attending care teams were aware of the allocated arm, patients were kept blinded to the allocation. Study investigators and outcome assessors could not be blinded as the data collection and analysis included outcome measures like timing of oral misoprostol solution doses.