Induction of Labor by Oral Misoprostol Solution

NCT04891679 | Completed

• 1 other identifier: Titrated and Static OMS
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Induction of Labor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Mean change in modified Bishop's score

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

• Number of misoprostol doses

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

• Time taken to give required doses

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

• Total misoprostol dosage

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

• Mode of delivery

  Upto 5 days from first dose of oral misoprostol solution

Study Arms (2)

Group A (Titrated OMS)

ACTIVE COMPARATOR

Titrated oral misoprostol solution

Drug: Oral misoprostol solution (OMS)

Group B (Static OMS)

ACTIVE COMPARATOR

Static oral misoprostol solution

Drug: Oral misoprostol solution (OMS)

Interventions

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 1. hour= 20ml 2. hour= 30ml 3. hour= 30ml 4. hour= 30ml 5. 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.

Group A (Titrated OMS); Group B (Static OMS)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant females were enrolled for induction of labor in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christian Medical College and Hospital, Ludhiana, India: lead

Study Sites (1)

Christian Medical College and Hospital

Ludhiana, Punjab, 141008, India

Location

Related Publications (2)

• 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.

  PMID: 27986461 BACKGROUND

• 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.

  PMID: 31006282 BACKGROUND

Study Officials

• SUNITA GOYAL, MBBS, MD

  Department of obstetrics and gynecology, Christian Medical College and hospital, Ludhiana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident, Department of obstetrics and gynecology

Model Details: Single center interventional single-blinded randomised controlled trial

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 18, 2021
• Study Start: December 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning immediately and ending 36 months following article publication.
• Access Criteria: Anyone who wishes to access the data for any purpose. Link will be made available at a later date.

Locations

IN (1)