Comparison of Oral Versus Vaginal Misoprostol for Labour... | NCT05957666

Studies
Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term

NCT05957666

Sponsor

Services Institute of Medical Sciences, Pakistan

Status

Unknown status

Last Update Posted

Jul 24, 2023Actual

Enrollment

176Estimated

Phase

Phase 2Phase 3

Conditions

Induction of Labour With Misoprostol

Interventions

Misoprostol Oral Tablet
vaginal misoprostol

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2023Actual

Primary Completion Date

Dec 16, 2023Estimated

Completion Date

Dec 16, 2023Estimated

First Submitted Date

Jul 15, 2023

First Submission Date that Met QC Criteria

Jul 15, 2023

First Posted Date

Jul 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2023

Last Update Posted Date

Jul 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tayyiba Wasim, Professor Obstetrics and Gynaecology, Services Institute of Medical Sciences, PakistanPrincipal Investigator

Lead Sponsor

Services Institute of Medical Sciences, PakistanOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

176Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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	Drug: vaginal misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol Oral Tablet	Drug	oral misoprostol 50 microgram repeated after 6 hours if required	oral misoprostol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
vaginal birth	vaginal birth within 24 hours of admission with 2 doses of misoprostol given 6 hours apart	vaginal birth within 24 hours of admission

Secondary Outcomes

Measure	Description	Time Frame
cesaerean section	cesaerean section if patient doesnt go in labour despite 2 doses or fetal distress occurs	within 24 hours
induction to delivery interval	measured from 1st dose till delivery of patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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) -

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tayyiba Wasim, FCPS	Contact	03008400197	92	tayyibawasim@yahoo.com
Kalsoom Waheed, FCPS	Contact	03214262687	92	zainabmohsin09@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Services Institute Of Medical Sciences	Recruiting	Lahore	Punjab Province	54000	Pakistan

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol

Ancestor Terms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

Masking Description

patients will either recieve oral or vaginal misoprostol by envelope method ina dose of 50microgram.Total of 176 envelopes are placed in a concealed box.Neither the doctor nor the patient knows.

Who Masked

ParticipantInvestigator