Induction of Labor by Oral Misoprostol Solution

Induction of Labor Clinical Trial

— OMS  

Official title:

A Randomised Control Study of Titrated and Static Oral Misoprostol for Induction of Labor at Term

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04891679
• Other study ID #: Titrated and Static OMS
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: May 2021
• Source: Christian Medical College and Hospital, Ludhiana, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Drug:
• Oral misoprostol solution (OMS)
Based on the WHO labor induction recommendation, and for the purpose of achieving precise oral misoprostol dosage, one misoprostol tablet (200 mcg) was pulverized and dissolved into 200 ml water.90 Thus 1ml of solution had 1mcg of misoprostol. This misoprostol solution could be preserved at room temperature and remained active for 24 hours. Hourly titrated oral misoprostol solution was given to group A as described by Wang X et al, 2016 as described below. 0 hour= 20ml hour= 20ml hour= 30ml hour= 30ml hour= 30ml hour= 40ml 6.5 hour= 50ml 8.5 hour= 60ml 10.5 hour=60ml Group B received 25 mcg (25 ml) oral misoprostol solution every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity.

Locations

Country	Name	City	State
India	Christian Medical College and Hospital	Ludhiana	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Christian Medical College and Hospital, Ludhiana, India

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interval between induction and delivery	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	From first dose of oral misoprostol solution (titrated/static) to childbirth; upto 5 days
Secondary	Mean change in modified Bishop's score	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.	From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Secondary	Number of misoprostol doses	Measured as 1-2; 3-4; 5-6; 7-8; >9	From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Secondary	Time taken to give required doses	Measured as 1-4 hours; 5-8 hours; 9-12 hours; 13-16 hours; 17-20 hours; 21-24 hours	From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Secondary	Total misoprostol dosage	Measured as	From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Secondary	Mode of delivery	In terms of Vaginal delivery/LSCS	Upto 5 days from first dose of oral misoprostol solution
Secondary	Indication for LSCS	Divided into either of the following: SECONDARY ARREST OF DILATATION; MSAF IN EARLY LABOR; CTG CATEGORY III; FAILED INDUCTION; CEPHALOPELVIC DISPROPORTION; CORD PROLAPSE; DEEP TRANSVERSE ARREST; ARREST OF DESCENT OF HEAD	Upto 5 days from first dose of oral misoprostol solution
Secondary	Oxytocin augmentation	Required/Not required	From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Secondary	Maternal morbidity	In terms of incidence of either of the following: Incidence of tachysystole; Fever- intrapartum and postpartum; Puerperal sepsis; Uterine rupture	From first dose of oral misoprostol solution to dischage from hospital; upto 7 days
Secondary	Neonatal parameters	Measured in terms of incidence of either of the following: Incidence of meconium-stained liquor; APGAR scores at 1,5 min; NICU stay	From childbirth to discharge of the baby; upto 1 month