Induction of LaborOMSNCT04891679

Induction of Labor by Oral Misoprostol Solution

A study testing Oral misoprostol solution (OMS) in people with Induction of Labor, run by Christian Medical College and Hospital, Ludhiana, India at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Induction of Labor
What is being tested?: Oral misoprostol solution (OMS)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 264 participants
Where: 1 siteIndia
Study dates: 1 Dec 2017to 30 Nov 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site

Christian Medical College and Hospital
Ludhiana, Punjab, 141008

Other trials in India

About this study

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

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.

Read the detailed 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.

Conditions: Induction of Labor
Being tested: Oral misoprostol solution (OMS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT04891679
Study group	Role	What they receive
Group A (Titrated OMS)	Active comparator	Titrated oral misoprostol solution Receives: Drug: Oral misoprostol solution (OMS)
Group B (Static OMS)	Active comparator	Static oral misoprostol solution Receives: Drug: Oral misoprostol solution (OMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: From first dose of oral misoprostol solution (titrated/static) to childbirth; upto 5 days

Secondary outcomes (9)

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.
Measured: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Number of misoprostol doses
Measured as 1-2; 3-4; 5-6; 7-8; >9
Measured: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
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
Measured: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Total misoprostol dosage
Measured as </=75mcg; 76-150mcg; 151-225mcg; 226-300mcg; >301 mcg
Measured: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Mode of delivery
In terms of Vaginal delivery/LSCS
Measured: Upto 5 days from first dose of oral misoprostol solution
Indication for LSCS
Divided into either of the following:
1. SECONDARY ARREST OF DILATATION
2. MSAF IN EARLY LABOR
3. CTG CATEGORY III
4. FAILED INDUCTION
5. CEPHALOPELVIC DISPROPORTION
6. CORD PROLAPSE
7. DEEP TRANSVERSE ARREST
8. ARREST OF DESCENT OF HEAD
Measured: Upto 5 days from first dose of oral misoprostol solution
Oxytocin augmentation
Required/Not required
Measured: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Maternal morbidity
In terms of incidence of either of the following:
1. Incidence of tachysystole
2. Fever- intrapartum and postpartum
3. Puerperal sepsis
4. Uterine rupture
Measured: From first dose of oral misoprostol solution to dischage from hospital; upto 7 days
Neonatal parameters
Measured in terms of incidence of either of the following:
1. Incidence of meconium-stained liquor
2. APGAR scores at 1,5 min
3. NICU stay
Measured: From childbirth to discharge of the baby; upto 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201730 Nov 2018

First posted18 May 2021
Study start1 Dec 2017
Primary completion30 Nov 2018
Study completion30 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Induction of LaborStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single center interventional single-blinded randomised controlled trial
Masking: Single blind
Who is masked: Participant
Enrolment: 264 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04891679
Sponsor's protocol ID: Titrated and Static OMS
Acronym: OMS
Status last verified: May 2021
First submitted: 13 May 2021
Last updated: 18 May 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD that underlie the results reported in the study, after deidentification (text, tables, figures and appendices) will be shared in the excel sheet format.

Publications

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.
PubMed 27986461
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.
PubMed 31006282

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety

All Induction of Labor trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Control Study of Titrated and Static Oral Misoprostol for Induction of Labor at Term
ClinicalTrials.gov ID: NCT04891679
Acronym / sponsor ID: OMS / Titrated and Static OMS
Conditions: Induction of Labor
Study type: Interventional
Recruitment status: Completed
Enrolment: 264 participants (actual)
Lead sponsor: Christian Medical College and Hospital, Ludhiana, IndiaUniversity, hospital or other
Study start: 1 Dec 2017 (actual)
Primary completion: 30 Nov 2018 (actual)
Study completion: 30 Nov 2018 (actual)
First posted: 18 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Primary and secondary outcome measures were noted and analyzed to compare safety and efficacy of titrated and oral misoprstol solution.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Single center interventional single-blinded randomised controlled trial

Arm	Type	Receives
Group A (Titrated OMS)	Active comparator	Drug: Oral misoprostol solution (OMS)Titrated oral misoprostol solution
Group B (Static OMS)	Active comparator	Drug: Oral misoprostol solution (OMS)Static oral misoprostol solution

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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 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.	Drug	Group A (Titrated OMS), Group B (Static OMS)

Primary outcome

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 1) <12 hours 2) 12-24 hours 3) 24-48 hours 4) >48 hours

9 secondary outcomes

Mean change in modified Bishop's score
Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Number of misoprostol doses
Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Time taken to give required doses
Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Total misoprostol dosage
Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Mode of delivery
Time frame: Upto 5 days from first dose of oral misoprostol solution
Indication for LSCS
Time frame: Upto 5 days from first dose of oral misoprostol solution
Oxytocin augmentation
Time frame: From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
Maternal morbidity
Time frame: From first dose of oral misoprostol solution to dischage from hospital; upto 7 days
Neonatal parameters
Time frame: From childbirth to discharge of the baby; upto 1 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
Background: PubMed 27986461Rouzi 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.
Background: PubMed 31006282Aduloju 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.
Individual participant dataSharing planned: Yes. IPD that underlie the results reported in the study, after deidentification (text, tables, figures and appendices) will be shared in the excel sheet format.

Related trials for Induction of Labor

Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

SUNITA GOYAL, MBBS, MD study chair

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Oral misoprostol solution (OMS) in people with Induction of Labor, run by Christian Medical College and Hospital, Ludhiana, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interval between induction and delivery (time frame: From first dose of oral misoprostol solution (titrated/static) to childbirth; upto 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04891679, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.