Effect of Intravenous Hyoscine Butylbromide Injection on... | NCT03055390

Studies
Effect of Intravenous Hyoscine Butylbromide Injection on Labour in High Risk Women

NCT03055390

Sponsor

Cairo University

Status

Completed

Last Update Posted

Mar 10, 2022Actual

Enrollment

300Actual

Phase

Phase 4

Conditions

Vaginal Delivery

Interventions

hyoscine butylbromide
placebo

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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 11, 2017Actual

Primary Completion Date

Jan 10, 2022Actual

Completion Date

Feb 3, 2022Actual

First Submitted Date

Feb 14, 2017

First Submission Date that Met QC Criteria

Feb 14, 2017

First Posted Date

Feb 16, 2017Actual

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

Mar 8, 2022

Last Update Posted Date

Mar 10, 2022Actual

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 case control trial Patients who meet the inclusion criteria were asked to participate in the study and a written consent was obtained from each patient after explaining thoroughly the nature and the scope of the study.

Patients were divided into three equal groups:

Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo.

Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously.

Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).

Detailed Description

For each patient:

Complete history was taking to exclude allergy to hyoscine butylbromide, medical disorders with pregnancy (preeclampsia, diabetes mellitus, heart disease …etc.) and any contraindication for vaginal delivery.
General examination of the patients including (pulse, blood pressure, temperature).
Obstetric Abdominal examination including fetal lie, fetal presentation, head station and uterine contractions.
Vaginal examination including cervical dilatation, effacement and position, state of fetal membranes, presenting part, position of fetal head and pelvic adequacy.
Obstetric ultrasound to detect fetal gestational age, fetal birth weight amount of liquor, site of placental attachment and fetal heart rate.

Patients were divided into three equal groups:

Group A: included 40 pregnant patients. They received two ml of normal saline intravenously as a placebo.

Group B: included 40 pregnant patients. They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously.

Group C: included 40 pregnant patients .They received two ml (40 mg) hyoscine butylbromide intravenously (HBB).

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	They received two ml of normal saline intravenously as a placebo	Drug: placebo
20 mg hyoscine butylbromide	Active Comparator	They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously	Drug: hyoscine butylbromide
40 mg hyoscine butylbromide	Active Comparator	They received (40mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously	Drug: hyoscine butylbromide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hyoscine butylbromide	Drug	Intravenous administration of hyoscine butylbromide during first stage of labor	20 mg hyoscine butylbromide 40 mg hyoscine butylbromide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of the first stage of labour	Duration of the first stage of labour	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 18 - 35 years old
Primigravdae or multigravida
Gestational age between completed 37- 41 weeks + 6 days.
Uncomplicated cephalic singleton pregnancy occipto-anterior position.
Established spontaneous active labour (defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation three to four centimeters) with cervical effacement not less than 50%.
Intact amniotic membranes.
High risk pregnancy (women with pregnancy induced hypertension- cardiac-Diabetes Mellitus

Exclusion Criteria:

Multigravidae.
Multiple fetus.
Malpresentation.
Patients with indications of elective caesarean section.
Medical conditions associated with pregnancy e.g. preeclampsia, diabetes mellitus.
Contraindications for hyoscine butylbromide which include known allergy to hyoscine or other atropinics (e.g., atropine, scopolamine), myasthenia gravis, megacolon or glaucoma.
Patients presented to causality with spontaneous rupture of membranes.
Spontaneous rupture of membranes during the active phase of first stage of labour.
Oxytocin induction or augmentation.
Patients who underwent epidural anesthesia or other types of analgesia

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ahmed Maged	Kasr Alainy medical school	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy medical school		Cairo		12151	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002086	Butylscopolammonium Bromide
C098223	2,3-dioleyloxy-N-(2-(sperminecarboxamido)ethyl)-N,N-dimethyl-1-propanaminium trifluoroacetate
D012965	Sodium Chloride

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided