Induction of Labor by Oral Misoprostol Solution

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Induction of Labor

Clinical Trial Details

NCT number	NCT04891679
Study type	Interventional
Source	Christian Medical College and Hospital, Ludhiana, India
Contact
Status	Completed
Phase	N/A
Start date	December 1, 2017
Completion date	November 30, 2018

View Details

See also
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Active, not recruiting	`NCT06324279` - Cervical Sliding Sign to Predict Outcome of Induction of Labor
Recruiting	`NCT05864326` - Heated Saline in Cervical Balloon for Labor Induction, a RCT	N/A
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Completed	`NCT04529837` - Ultrasound Assessment of DILAPAN-S
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Completed	`NCT03138252` - Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin	Phase 3
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Not yet recruiting	`NCT05511727` - Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening	N/A
Recruiting	`NCT02762942` - Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor	Phase 4
Completed	`NCT01283022` - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)	Phase 2
Recruiting	`NCT00684606` - Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor	N/A
Recruiting	`NCT05759364` - The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain	N/A
Recruiting	`NCT03854383` - Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women	Phase 2
Completed	`NCT01428037` - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor	Phase 3
Terminated	`NCT03752073` - Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix	N/A
Recruiting	`NCT03045939` - Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Induction of Labor by Oral Misoprostol Solution — OMS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms