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Completed

NCT Number: NCT04891679

Induction of Labor by Oral Misoprostol Solution

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Christian Medical College and Hospital

Ludhiana, Punjab, 141008, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton live pregnancy;
  • ≥37 weeks gestation;
  • Cephalic presentation;
  • Reassuring fetal heart rate;
  • Modified Bishop'score

Exclusion criteria

  • 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

Treatment and study plan

Oral misoprostol solution (OMS)

Drug

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.

Primary outcomes

  1. Interval between induction and delivery

    Time frame: 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

    • <12 hours 2) 12-24 hours 3) 24-48 hours 4) >48 hours

Secondary outcomes

  1. Mean change in modified Bishop's score

    Time frame: 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.

  2. Number of misoprostol doses

    Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days

    Measured as 1-2; 3-4; 5-6; 7-8; >9

  3. Time taken to give required doses

    Time frame: 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

  4. Total misoprostol dosage

    Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days

    Measured as </=75mcg; 76-150mcg; 151-225mcg; 226-300mcg; >301 mcg

  5. Mode of delivery

    Time frame: Upto 5 days from first dose of oral misoprostol solution

    In terms of Vaginal delivery/LSCS

  6. Indication for LSCS

    Time frame: Upto 5 days from first dose of oral misoprostol solution

    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
  7. Oxytocin augmentation

    Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days

    Required/Not required

  8. Maternal morbidity

    Time frame: From first dose of oral misoprostol solution to dischage from hospital; upto 7 days

    In terms of incidence of either of the following:

    • Incidence of tachysystole
    • Fever- intrapartum and postpartum
    • Puerperal sepsis
    • Uterine rupture
  9. Neonatal parameters

    Time frame: From childbirth to discharge of the baby; upto 1 month

    Measured in terms of incidence of either of the following:

    • Incidence of meconium-stained liquor
    • APGAR scores at 1,5 min
    • NICU stay

Sponsors and collaborators

Lead sponsor

Christian Medical College and Hospital, Ludhiana, India

Other

Registry information

Official study title

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

Acronym: OMS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 18, 2021
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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