Effect of Hyoscine- Bromide on Duration of the First Stag... | NCT06056869

Studies
Effect of Hyoscine- Bromide on Duration of the First Stage of Labor

NCT06056869

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Oct 6, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Labor

Interventions

hyoscine butylbromide
normal saline

Countries

Egypt

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

Oct 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

Sep 27, 2023Actual

Primary Completion Date

Apr 2024Estimated

Completion Date

Apr 2024Estimated

First Submitted Date

Sep 21, 2023

First Submission Date that Met QC Criteria

Sep 21, 2023

First Posted Date

Sep 28, 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

Oct 5, 2023

Last Update Posted Date

Oct 6, 2023Actual

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

Spasmolytic drugs are frequently used in delivery rooms to overcome cervical spasms and thus reduce the duration of labor. The aim of this randomized double blind placebo controlled trial is to study the efficacy of hyoscine butylbromide (HBB) for shortening of the first stage of labor in primigravid women.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
buscopan group	Active Comparator	will receive 2 ml (40 mg) of hyoscine butylbromide	Drug: hyoscine butylbromide
control group	Placebo Comparator	will receive 2 ml of normal saline	Other: normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hyoscine butylbromide	Drug	will be given during first stage of labor intravenously	buscopan group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
duration of first stage of labor	duration	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primigravid women.
Singleton pregnancy.
Presenting by the vertex.
Gestational age between 37 and 42 weeks
In active phase of labor with a cervical dilatation between 4-5 cm, with either intact membranes or spontaneous rupture of membranes for less than 12 h

Exclusion Criteria:

Previous uterine scarring.
Malpresentation.
Antepartum hemorrhage.
Labor induction
Contraindication to vaginal delivery.
Contraindication to hyoscine.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

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
Maii Nawara, MD	Contact	+201001848388		maii_nawara@hotmail.com

Overall Officials

Name	Affiliation	Role
Maii Nawara	Associate professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University maternity hospital	Recruiting	Cairo	Cairo/القاهرة		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

will be available with principal investigator if required

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002086	Butylscopolammonium Bromide
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals
D012602	Scopolamine Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided