- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02098889
Safety Study of Hyoscine N Butyl Bromide in Active Management of Labor (HBB)
Efficacy and Safety of Hyoscine N Butyl Bromide on the Augmentation of Labor: a Double-Blind, Placebo - Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators aimed to study the effects and safety of 20mg intravenous HBB for the shortening of labor in both prima- and multigravid women.The study designed as a double blind, randomized, controlled trial comparing the two groups of intervention; Intravenous 20 mg (1mL) Hyoscine-N-Butylbromide (HBB) versus placebo (1mL saline) in both primigravid and multigravid women.Singleton, vertex presentation at term (gestational age range; 37-41weeks) primigravid and multigravid women without any chronic and pregnancy-induced diseases were included to the study. The investigators excluded the cases with premature rupture of membranes, preeclampsia, eclampsia, placental abruption, placenta previa, abnormal placental attachment, twin pregnancy, non- cephalic presentations, previous uterine surgery and cephalopelvic disproportion.Randomization was done by using cards .The women were allocated into two groups by using a sealed enveloped system.A yellow and a red card were placed separately in each sealed envelope. The syringes containing the drug and placebo were prepared by the investigational pharmacy staff and labeled with a yellow or red sticker on it. Each syringe contained either 1ml(20mg) of Hyoscine-N-Butylbromide (HBB) (MOLIT ampule,Adeko, Turkey) or 1 ml of normal saline solution (placebo) in which both of the liquids are colorless. The participants, nurses and doctors were all blinded to syringes. The patients were asked to pick up one envelope in order and the color of the card was corresponding to the sticker's color on the syringe.Nurses applied the selected color labeled syringe to each patient. Participants received the contents of the syringe as a single dose, given intravenously (IV).
A partogram was drawn and vaginal examinations recorded in every 2 hours.The active phase of labor was defined as 4 cm cervical dilatation and 50% cervical effacement in the presence of regular uterine contractions (2-3 contractions in every 10 minutes). The drug was given only once when the active phase was achieved. Iatrogenic amniotomy was performed for women who did not have a spontaneous rupture of membrane at the time when the cervical ripening was 8 cm. The duration of labor during the first, second and third stages, oxytocin induction, iatrogenic amniotomy, pre- and postpartum haemoglobin levels, birth weight and APGAR scores were recorded. Neonatal APGAR scores were determined 1 and 5 minutes after birth.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Marmara
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Istanbul, Marmara, Turkey, 34100
- Sisli Etfal Research and Training hospital, Obstetrics and gynecology department
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Singleton, vertex presentation at term (gestational age range; 37-41weeks) primigravid and multigravid women without any chronic and pregnancy-induced diseases
Exclusion Criteria:
- The cases with premature rupture of membranes, preeclampsia, eclampsia, placental abruption, placenta previa, abnormal placental attachment, twin pregnancy, non- cephalic presentations, previous uterine surgery and cephalopelvic disproportion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: hyoscine-N-butyl bromide
A single dose intravenously(IV) 20ml hyoscine-N-butyl bromide(HBB) versus placebo ( a single dose 20ml IV NaCl) on the active phase of labor
|
A single dose intravenously(IV) 20 mg (20ml) hyoscine-N-butyl bromide(HBB) versus placebo ( a single dose of 20ml IV NaCl) on the active phase of labor
Other Names:
|
Placebo Comparator: Saline(0,9NaCl)
Placebo ( a single dose of 20ml IV NaCl) versus A single dose intravenously(IV) 20 mg (20ml) hyoscine-N-butyl bromide(HBB)on the active phase of labor
|
placebo ( a single dose of 20ml IV NaCl) versus A single dose intravenously(IV) 20 mg (20ml) hyoscine-N-butyl bromide(HBB)on the active phase of labor
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of HBB on the active management of labor
Time Frame: up to 7 month
|
The aim of the active management of labor is to shorten the duration of labor without an increase in maternal or fetal morbidity and mortality.
Appropriate cervical dilatation and effacement are essential for the progression of labor.
Our study designed to evaluate the effects of HBB on cervical dilatation and demonstrated the efficacy of HBB in augmenting labor.
We are going to measure cervical effacement and dilation in every 2 hours to evaluate the progression of labor.
To evaluate the effect of HBB on active phase of labor, we will measure the time (in minutes) between the active phase of labor and delivery.The measured time difference is going to give us 'does HBB has any effects on the shortening of active phase of labor'.
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up to 7 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and efficacy of HBB on maternal outcomes
Time Frame: up to 7 month
|
Maternal complications of drug-related side effects (nausea, vomiting, pruritus, rash, mouth establishment, collided), postpartum hemorrhage (more than 500cc), 3th or 4th degree vaginal tears, intrapartum chorioamnionitis (38 ° C higher fever, vaginal temperature increase, uterine tenderness, or Fetal heart rate above 160 to be), postpartum endometritis (first 24 hours, 38 ° C higher with fever uterine tenderness, purulent foul-smelling discharge) covers.
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up to 7 month
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Safety and efficacy of HBB on fetal outcomes
Time Frame: up to 7 month
|
The 5th minute Apgar score of neonatal complications (5 Min.
7 below), feeding intolerance, neonatal jaundice, Transient tachypnea of the newborn (TTN), hypoglycemia, neonatal sepsis and intensive care unit covers the need.
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up to 7 month
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Collaborators and Investigators
Investigators
- Principal Investigator: Osman Asıcıoglu, Serpil KIRIM,Begum AYDOGAN,Nazlı YENIGUL
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Antiemetics
- Gastrointestinal Agents
- Adjuvants, Anesthesia
- Anticonvulsants
- Mydriatics
- Bromides
- Scopolamine
- Butylscopolammonium Bromide
Other Study ID Numbers
- 179
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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