Effect of Intravenous Hyoscine Butylbromide Injection on First Stage Labour in Primigavidae

NCT02824679 | Completed Phase 4

• 1 other identifier: 150
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

A case control study conducted on 120 women coming to Cairo University Maternity Hospital .Patients who meet the inclusion criteria were asked to participate in the study and a verbal consent was obtained from each patient. Patients will be divided into three equal groups (A, B, C). A single dose of the drug (placebo or HBB 20mg or HBB 40 mg) will be injected intravenously slowly to groups A, B, C respectively. Labouring mothers will be monitored in bed. Vaginal examination will be conducted every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labour until a fully dilated cervix will be observed

Conditions

Vaginal Delivery

Keywords

Normal labour; Augmentation of labour; Hyoscine butylbromide

Outcome Measures

Primary Outcomes (1)

• first stage duration

  time till cervix become fully dilated

  12 hours after drug intake

Secondary Outcomes (1)

• Mode of delivery

  12 hours after drug intake

Study Arms (3)

20mg hyoscine butylbromide

ACTIVE COMPARATOR

They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously

Drug: hyoscine butylbromide; Drug: saline

40 mg hyoscine butylbromide

ACTIVE COMPARATOR

They received (40mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously

Drug: hyoscine butylbromide

Saline

PLACEBO COMPARATOR

They received two ml of normal saline intravenously as a placebo

Drug: saline

Interventions

hyoscine butylbromide DRUG

20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor

20mg hyoscine butylbromide; 40 mg hyoscine butylbromide

saline DRUG

0.9%normal saline

20mg hyoscine butylbromide; Saline

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 - 35 years old
• Primigravdae.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmed M Maged, MD: lead

MeSH Terms

Interventions

Butylscopolammonium Bromide; Sodium Chloride

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ahmed Maged, MD

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 2, 2016
• First Posted: July 7, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share