Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201402000736158 Date of Approval: 07/01/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Active management of the third stage of labor: Uterine Tonus Assessment by Midwife vs. Patient self-administration
Official scientific title Active management of the third stage of labor: Uterine Tonus Assessment by Midwife vs. Patient self-administration
Brief summary describing the background and objectives of the trial Rationale: Postpartum haemorrhage (PPH) is the most common cause of maternal death worldwide. The active management of the third stage of labour (AMTSL) is recognized as an effective strategy to prevent morbidity and mortality associated with PPH and reduce blood loss. AMTSL includes the provision of uterotonic drugs, controlled cord traction, delayed cord clamping and cutting, massage of the uterus, and monitoring of the uterine tonus. Although professional guidelines recommend the steps of AMTSL to be performed by health professionals, the reality of hospital understaffing in many low- and middle income countries (LMICs) necessitates task-shifting of the final AMTSL component to patients. Yet, whether uterus tonus assessment yields the same effect when performed by patients and midwives has not been formally evaluated. Objective: To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum hemorrhage. mean blood loss, and other maternal and neonatal outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) UTAMP
Disease(s) or condition(s) being studied Postpartum hemorrhage,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/03/2014
Actual trial start date
Anticipated date of last follow up 31/07/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 800
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Participants will be assigned a study identification code, based on consecutive enrolment. Investigators have access to the source data. The key to the code will remain with the coordinating investigator. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Uterine tonus assessment by a midwife every 15 minutes 2 hours 2. uterus tonus assessment by midwife, every 15 minutes for 2 hours (guideline recommended practice) 386
Control Group Uterine tonus assessment by patient every 15 minutes 2 hours 1. uterus tonus assessment by patient, every 15 minutes for 2 hours (current standard practice) 386 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age ¿ 18 years - Be in labor with an expected vaginal delivery, as assessed by the midwives - Gestation age ¿ 37 weeks - Received antenatal instructions on postnatal uterine tonus assessment - Provided informed consent. ¿ Age <18 ¿ Elective caesarean delivery ¿Severe anemia (<8g/dL) ¿Placenta praevia ¿Anticipated breech delivery ¿Referred patients who have not received ANC uterine tonus assessment instructions ¿Multiple pregnancy ¿Intra uterine fetal death 18 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No Ethical and Protocol Review Committee, University of Ghana Medical School
Ethics Committee Address
Street address City Postal code Country
Accra Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 16/01/2014 Medical Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Heidelberglaan 100 Utrecht 3584 CX Netherlands
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postpartum hemorrhage (>500 ml blood loss) Continuously
Secondary Outcome Severe post-partum hemorrhage (>1000ml blood loss) Continuously
Secondary Outcome Use of additional uterotonics Continuously
Secondary Outcome Use of other procedures for management of postpartum hemorrhage (surgery, manual placenta tissue removal) Continuously
Secondary Outcome Late (>24 hours) postpartum hemorrhage If this occurs
Secondary Outcome Blood transfusion If this occurs
Secondary Outcome Maternal resuscitation If this occurs
Secondary Outcome Maternal death If this state occurs
Secondary Outcome Apgar scores at 1 and 5 minutes At 1 and 5 minutes
Secondary Outcome Neonatal resuscitation If this occurs
Secondary Outcome Perinatal death If this occurs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Korle Bu Teaching Hospital Guggisberg Avenue Accra P.O.Box kb77 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Korle Bu Teaching Hospital Guggisberg Avenue Accra P.O.Box kb77 Ghana
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht Universiteitsweg 100 Utrecht 3508 GA Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht Universiteitsweg 100 Utrecht 3508GA Netherlands Hospital
Primary Sponsor Korle Bu Teaching Hospital Guggisberg Avenue Accra P.O.Box kb77 Ghana Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr. Nelson K.R. Damale Korle Bu Teaching Hospital Accra ndamale@yahoo.co.uk Ghana
Prof. Kerstin Klipstein-Grobusch Universiteitsweg 100 Utrecht 3508GA Netherlands
Dr. Joyce L. Browne Universiteitsweg 100 Utrecht 3508GA Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nelson Damale ndamale@yahoo.co.uk +233 246551111 Guggisberg Avenue
City Postal code Country Position/Affiliation
Accra Ghana Senior Lecturer, gynaecologist
Role Name Email Phone Street address
Principal Investigator Joyce Browne J.L.Browne@umcutrecht.nl +31649650071 Heidelberglaan 100
City Postal code Country Position/Affiliation
Utrecht 3584CX Netherlands PhD candidate
Role Name Email Phone Street address
Public Enquiries Joyce Browne J.L.Browne@umcutrecht.nl 31649650071 Universiteitsweg 100
City Postal code Country Position/Affiliation
Utrecht 3584CX Netherlands PhD candidate
Role Name Email Phone Street address
Scientific Enquiries Joyce Browne J.L.Browne@umcutrecht.nl 31649650071 Universiteitsweg 100
City Postal code Country Position/Affiliation
Utrecht 3584CX Netherlands PhD candidate
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information