Induction of Labour With MisoprostolPhase 2/3NCT05957666
Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term
A Phase 2/3 study testing Misoprostol Oral Tablet and vaginal misoprostol in people with Induction of Labour With Misoprostol, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial summary
A randomised control trial to compare oral and vaginal misoprostol for induction of labour in term patients.The objective is to determine whether use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of lessthan or equal to 6 who require induction… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labour With Misoprostol
- What is being tested?
- Misoprostol Oral Tablet and vaginal misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Jun 2023to 16 Dec 2023
- Phase
- Phase 2/3
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cephalic presentation Prelabour rupture of membranes Singleton pregnancies reaching 41 weeks G1 to G4 Bishop score of less than or equal to 6 Medical disorders(GDM,PIH) -
Who cannot join
- Previous uterine scar Antepartum hemorrhage Cephalopelvic disproportion Multiple gestation Multiparity Oligohydramnios/polyhydramnios IUGR Severe systemic illness like pre eclampsia,eclampsia,cardiac,hepatic,renal disease PPROM
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Services Institute Of Medical Sciences
Lahore, Punjab Province, 54000
Tayyiba Wasim, FCPS, 03008400197 ext. 92, tayyibawasim@yahoo.com
Kalsoom Waheed, FCPS, 03214262687 ext. 92, zainabmohsin09@gmail.com
About this study
A randomised control trial to compare oral and vaginal misoprostol for induction of labour in term patients.The objective is to determine whether use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of lessthan or equal to 6 who require induction of labpour at term compared to oral misoprostol regimen.
Read the detailed description
The objective of study is to determine whether the use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of less than or equal to 6 who require induction of labour at term compared to oral misoprostol regimen.It is a randomised control trial conducted in department of obs and gynae unit 1 from june 2023.
Total 176 patients are included in this study and they will be randomised by envelope method to recieve either oral or vaginal misoprostol in a dose of 50microgram.In both groupds dose will be repeated after 6 hours if required.Maximum 2 doses will be given.patients will be monitored for uterine contractions and fetal hearts.Vaginal examination will be done at 4hours and 8 hours following misoprostol dose or earlier if patient complains of leaking and labour pains.Membranes will be ruptured once cervical dilatation is greater than 3cm.in absence of adequate uterine contractions oxytocin infusion will be started.Fetal hearts will be monitored every 30 minutes from time of induction.Progress of labour will be assessed through partogram.
- Conditions
- Induction of Labour With Misoprostol
- Being tested
- Misoprostol Oral Tablet, vaginal misoprostol
- Keywords
- induction of labour, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol Oral TabletDrug
Also called cytotec
oral misoprostol 50 microgram repeated after 6 hours if required
vaginal misoprostolDrug
Also called cytotec
vaginal misoprostol 50 microgram repeated after 6 hours if required
| Study group | Role | What they receive |
|---|---|---|
| oral misoprostol | Experimental | oral misoprostol will be given in a dose of 50microgram and repeated after 6 hours if required.Maximum 2 doses will be given Receives: Drug: Misoprostol Oral Tablet |
| vaginal misoprostol | Active comparator | vaginal misoprostol will be given in a dose of 50 microgram and repeated after 6 hours if required.Maximum 2 doses will be given Receives: Drug: vaginal misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaginal birth
vaginal birth within 24 hours of admission with 2 doses of misoprostol given 6 hours apart
Measured: vaginal birth within 24 hours of admission
Secondary outcomes (4)
cesaerean section
cesaerean section if patient doesnt go in labour despite 2 doses or fetal distress occurs
Measured: within 24 hours
induction to delivery interval
measured from 1st dose till delivery of patient
Measured: within 24 hours
fetal distress
fetal distress measured by non reactive CTG or meconium stained amniotic fluid
Measured: within 24 hours
uterine hyperstimulation
more than 5 contractions in every 10 minutes
Measured: more than 10 cotractions in every 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start16 Jun 2023
- Primary completion16 Dec 2023 (estimated)
- Study completion16 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Labour With MisoprostolStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Total 176 patient included in this study.Patients will be randomised by envelop method to recieve either oral or vaginal misoprostol in a dose of 50microgram.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tayyiba Wasim, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957666
- Sponsor's protocol ID
- IRB/2023/1129/SIMS
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term
- ClinicalTrials.gov ID
- NCT05957666
- Acronym / sponsor ID
- IRB/2023/1129/SIMS
- Conditions
- Induction of Labour With Misoprostol
- Keywords
- induction of labour, misoprostol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 16 Dec 2023 (estimated)
- Study completion
- 16 Dec 2023 (estimated)
- First posted
- 24 Jul 2023 (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.
A randomised control trial to compare oral and vaginal misoprostol for induction of labour in term patients.The objective is to determine whether use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of lessthan or equal to 6 who require induction of labpour at term compared to oral misoprostol regimen.
Detailed description
The objective of study is to determine whether the use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of less than or equal to 6 who require induction of labour at term compared to oral misoprostol regimen.It is a randomised control trial conducted in department of obs and gynae unit 1 from june 2023.
Total 176 patients are included in this study and they will be randomised by envelope method to recieve either oral or vaginal misoprostol in a dose of 50microgram.In both groupds dose will be repeated after 6 hours if required.Maximum 2 doses will be given.patients will be monitored for uterine contractions and fetal hearts.Vaginal examination will be done at 4hours and 8 hours following misoprostol dose or earlier if patient complains of leaking and labour pains.Membranes will be ruptured once cervical dilatation is greater than 3cm.in absence of adequate uterine contractions oxytocin infusion will be started.Fetal hearts will be monitored every 30 minutes from time of induction.Progress of labour will be assessed through partogram.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Total 176 patient included in this study.Patients will be randomised by envelop method to recieve either oral or vaginal misoprostol in a dose of 50microgram.
| Arm | Type | Receives |
|---|---|---|
| oral misoprostol | Experimental | Drug: Misoprostol Oral Tabletoral misoprostol will be given in a dose of 50microgram and repeated after 6 hours if required.Maximum 2 doses will be given |
| vaginal misoprostol | Active comparator | Drug: vaginal misoprostolvaginal misoprostol will be given in a dose of 50 microgram and repeated after 6 hours if required.Maximum 2 doses will be given |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Cephalic presentation Prelabour rupture of membranes Singleton pregnancies reaching 41 weeks G1 to G4 Bishop score of less than or equal to 6 Medical disorders(GDM,PIH) -
Key exclusion criteria (2 listed)
- Previous uterine scar Antepartum hemorrhage Cephalopelvic disproportion Multiple gestation Multiparity Oligohydramnios/polyhydramnios IUGR Severe systemic illness like pre eclampsia,eclampsia,cardiac,hepatic,renal disease PPROM
- -
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 |
|---|---|---|
| Misoprostol Oral TabletAlso: cytotecoral misoprostol 50 microgram repeated after 6 hours if required | Drug | oral misoprostol |
| vaginal misoprostolAlso: cytotecvaginal misoprostol 50 microgram repeated after 6 hours if required | Drug | vaginal misoprostol |
Primary outcome
vaginal birth
Time frame: vaginal birth within 24 hours of admission
vaginal birth within 24 hours of admission with 2 doses of misoprostol given 6 hours apart
4 secondary outcomes
cesaerean section
Time frame: within 24 hours
induction to delivery interval
Time frame: within 24 hours
fetal distress
Time frame: within 24 hours
uterine hyperstimulation
Time frame: more than 10 cotractions in every 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
Related trials for Induction of Labour With Misoprostol
Not yet recruitingPhase 4
Combined Misoprostol and Cervical Balloon vs Misoprostol Alone for Induction on the First Day in Primiparas
Primiparous Women
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Misoprostol Oral Tablet and vaginal misoprostol in people with Induction of Labour With Misoprostol, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. 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 Pakistan. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tayyiba Wasim, FCPS (03008400197 ext. 92, tayyibawasim@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaginal birth (time frame: vaginal birth within 24 hours of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2023.