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

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ClinicalTrials.gov Identifier: NCT02824679
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

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

Condition or disease Intervention/treatment Phase
Vaginal Delivery Drug: hyoscine butylbromide Drug: saline Phase 4

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intravenous Hyoscine Butylbromide Injection on the Course and Duration of First Stage of Labour in Primigavidae
Actual Study Start Date : July 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 20mg hyoscine butylbromide
They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously
Drug: hyoscine butylbromide
20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor

Drug: saline
0.9%normal saline

Active Comparator: 40 mg hyoscine butylbromide
They received (40mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously
Drug: hyoscine butylbromide
20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor

Placebo Comparator: Saline
They received two ml of normal saline intravenously as a placebo
Drug: saline
0.9%normal saline




Primary Outcome Measures :
  1. first stage duration [ Time Frame: 12 hours after drug intake ]
    time till cervix become fully dilated


Secondary Outcome Measures :
  1. Mode of delivery [ Time Frame: 12 hours after drug intake ]
    Normal vaginal or cesarean section



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 18 - 35 years old
  2. Primigravdae.
  3. Gestational age between completed 37- 41 weeks + 6 days.
  4. Uncomplicated cephalic singleton pregnancy occipto-anterior position.
  5. 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%.
  6. Intact amniotic membranes.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824679


Sponsors and Collaborators
Ahmed Maged
Investigators
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Principal Investigator: Ahmed Maged, MD Kasr Alainy medical school
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Responsible Party: Ahmed Maged, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT02824679    
Other Study ID Numbers: 150
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Ahmed Maged, Cairo University:
Normal labour
Augmentation of labour
Hyoscine butylbromide
Additional relevant MeSH terms:
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Scopolamine
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics