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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055390
Recruitment Status : Unknown
Verified April 2017 by Ahmed Maged, Cairo University.
Recruitment status was:  Recruiting
First Posted : February 16, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

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).


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

Detailed Description:

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.

For each patient:

  1. 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.
  2. General examination of the patients including (pulse, blood pressure, temperature).
  3. Obstetric Abdominal examination including fetal lie, fetal presentation, head station and uterine contractions.
  4. Vaginal examination including cervical dilatation, effacement and position, state of fetal membranes, presenting part, position of fetal head and pelvic adequacy.
  5. 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Study the Effect of Intravenous Hyoscine Butylbromide Injection on the Duration and Progress of First Stage Labour in High Risk Women
Actual Study Start Date : February 11, 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
They received two ml of normal saline intravenously as a placebo
Drug: placebo
2ml of saline intravenous
Other Name: saline

Active Comparator: 20 mg hyoscine butylbromide
They received (20mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously
Drug: hyoscine butylbromide
Intravenous administration of hyoscine butylbromide during first stage of labor
Other Name: Dospa

Active Comparator: 40 mg hyoscine butylbromide
They received (40mg) hyoscine butylbromide (one ml HBB+ one ml saline) intravenously
Drug: hyoscine butylbromide
Intravenous administration of hyoscine butylbromide during first stage of labor
Other Name: Dospa




Primary Outcome Measures :
  1. Duration of the first stage of labour [ Time Frame: 24 hours ]
    Duration of the first stage of labour



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
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 18 - 35 years old
  2. Primigravdae or multigravida
  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.
  7. High risk pregnancy (women with pregnancy induced hypertension- cardiac-Diabetes Mellitus

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): NCT03055390


Contacts
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Contact: Ahmed Maged 01005227404 prof.ahmedmaged@gmail.com

Locations
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Egypt
Kasr Alainy medical school Recruiting
Cairo, Egypt, 12151
Contact: Ahmed Maged, MD    01005227404    prof.ahmedmaged@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged Kasr Alainy medical school
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Responsible Party: Ahmed Maged, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03055390    
Other Study ID Numbers: 158
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ahmed Maged, Cairo University:
hyoscine butylbromide
progress of labor
duration of labor
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