ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	TCTR
Last refreshed on:	1 April 2024
Main ID:	TCTR20180123004
Date of registration:	23/01/2018
Prospective Registration:	No
Primary sponsor:	Anthony Wanjala, David Kaihura, Benjamin Chemwolo, Kays Muruka
Public title:	COMPARISON OF 60MG AND 40MG DOSES OF HYOSCINE BUTYLBROMIDE ON LABOR OUTCOMES AT MOI TEACHING AND REFERRAL HOSPITAL, ELDORET, KENYA.
Scientific title:	COMPARISON OF 60MG AND 40MG DOSES OF HYOSCINE BUTYLBROMIDE ON LABOR OUTCOMES AT MOI TEACHING AND REFERRAL HOSPITAL, ELDORET, KENYA
Date of first enrolment:	03/01/2014
Target sample size:
Recruitment status:	Completed
URL:	https://www.thaiclinicaltrials.org/show/TCTR20180123004
Study type:	Interventional
Study design:	Randomized
Phase:	N/A

Countries of recruitment
Kenya

Contacts

Name:	Anthony Wanjala
Address:	150 - 50103 50103 Kakamega Kenya
Telephone:	+254720679226
Email:	anthonynakhisa@gmail.com
Affiliation:	Malava County Hospital, Kakamega

Name:	Anthony Wanjala
Address:	150 - 50103 50103 Kakamega Kenya
Telephone:	+254720679226
Email:	anthonynakhisa@gmail.com
Affiliation:	Malava County Hospital, Kakamega

Key inclusion & exclusion criteria

Inclusion criteria: Prim gravid women
Term gestation
18 years or older
Singleton gestation
Cephalic presentation
Spontaneous labor
Exclusion criteria: Hypersensitivity to Hyoscine Butyl Bromide
Contra-indication to vaginal delivery and
Scarred uterus.

At the point of administering the drug those with
Chorioamnionitis
Ante-partum hemorrhage
Those who withdrew their consent
Intra-uterine fetal demise
Cervical dilatation > 5cm

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Effect of 60mg and 40mg of Hyoscine Butyl Bromide on Duration of active phase labor. Mode of Delivery Neonatal Apgar scores Amount of Blood Loss after Delivery
Hyoscine Butyl Bromide
Labor
Buscopan

Hyoscine Butyl Bromide
Labor
Buscopan

Intervention(s)

Study Arm,Control Arm

60mg of IV Hyoscine Butylbromide given to women in early active phase of labor i.e 4 - 5cm of cervical dilatation. Labor monitored as per the standard WHO partograph.,40mg of IV Hyoscine Butylbromide given to women in early active phase of labor i.e 4 - 5cm of cervical dilatation. Labor monitored as per the standard WHO partograph.

Active Comparator Drug,Active Comparator Drug

Primary Outcome(s)

Injection of drug (at 4 - 5 cm) to delivery time During labor Minutes

Secondary Outcome(s)

Mode of delivery At delivery Vaginal Delivery or Cesarean section,Neonatal Apgar scores Within 10 minutes of delivery 0 - 10

Secondary ID(s)

Source(s) of Monetary Support

Self

Secondary Sponsor(s)

Ethics review

Status: Submitted, approved
Approval date:
Contact:

Institutional Review & Ethics Committee, Moi University School of Medicine

+254722475227 Ext.

Results

Results available:
Date Posted:
Date Completed:	30/04/2014
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.