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Trial record 6 of 280 for:    Panama

Hyoscine Butylbromide Effect on Duration of Labor

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ClinicalTrials.gov Identifier: NCT03441217
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Sistema Nacional de Investigadores de Panamá
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Brief Summary:
To evaluate the duration of labour (active phase of labour) in nulliparous women with gestations between 37 and 41 6/7 weeks when 20 mg of Hyoscine butylbromide was applied intravenously and compared with similar patients that received a placebo.

Condition or disease Intervention/treatment Phase
Labor Drug: Hyoscine Butylbromide 20Mg/1mL Injection Drug: Saline Solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyoscine Butylbromide Effect on Duration of Labor in Nulliparous Women: A Randomized, Double Blind, Controlled Trial
Actual Study Start Date : July 12, 2019
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hyoscine Butylbromide 20Mg/1mL Injection
Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide IV upon arrival in the Labor and Delivery Unit (4-5 cms).
Drug: Hyoscine Butylbromide 20Mg/1mL Injection
Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide upon arrival in the Labor and Delivery Unit (4-5 cms).

Placebo Comparator: Saline solution
Nulliparous women with gestations at term receive Saline Solution IV upon arrival in the Labor and Delivery Unit (4-5 cms).
Drug: Saline Solution
Nulliparous women with gestations at term receive 20 mg of saline solution upon arrival in the Labor and Delivery Unit (4-5 cms).




Primary Outcome Measures :
  1. Duration of first stage of labor [ Time Frame: 24 hours ]
    Time measured from the moment the patient receive the allocated medication/placebo to complete dilation

  2. Rate of cervical dilation [ Time Frame: 24 hours ]
    Speed of cervical dilation (cms/hour) from the moment the patient receive the allocated medication/placebo to complete dilation


Secondary Outcome Measures :
  1. Duration of labor [ Time Frame: 24 hours ]
    Time measured from the moment the patient receive the allocated medication/placebo to delivery

  2. Fetal and neonatal complications [ Time Frame: 72 hours ]
    Number of adverse events (fetal or neonatal)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low risk gestation between 37 and 41 6/7 weeks.
  • Cephalic (vertex) presentation.
  • Spontaneous labor in active phase (4 cms)

Exclusion Criteria:

  • Premature rupture of membranes upon arrival at the Labor and Delivery Unit > 4 hours.
  • Multiple order pregnancy.
  • Stillbirth.
  • Any fetal condition that could interfere in the mode of delivery (macrosomia, fetal growth restriction, oligohydramnios).

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): NCT03441217


Contacts
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Contact: Navarro Lorena, MD 5075619 navarro_lore28@hotmail.com
Contact: Geneva González, MD 5075619

Locations
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Panama
Saint Thomas Maternity Hospital Recruiting
Panama, Panama
Contact: Osvaldo A Reyes, MD (Gyn/Ob)    011(507)65655041    oreyesmaternidad@gmail.com   
Contact: Gerardo Cárdenas, MD (Gyn/Ob)         
Principal Investigator: Osvaldo A Reyes, MD (Gyn/Ob)         
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Sistema Nacional de Investigadores de Panamá
Investigators
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Study Director: Osvaldo Reyes, MD Maternidad del Hospital Santo Tomás

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Responsible Party: Osvaldo A. Reyes T., Head - Research Department, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT03441217     History of Changes
Other Study ID Numbers: MHST2014-05
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Duration of labor
Hyoscine butylbromide
Additional relevant MeSH terms:
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Scopolamine
Pharmaceutical Solutions
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