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.: PACTR202001882345033 Date of Approval: 13/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of cranial uterine traction on the incidence of postpartum hemorrhage: A randomized clinical trial
Official scientific title The effect of cranial uterine traction on the incidence of postpartum hemorrhage: A randomized clinical trial
Brief summary describing the background and objectives of the trial Globally, between one-quarter to one-third of maternal deaths have been reported to be caused by postpartum hemorrhage (PPH)1-3, with prevalence rates varying widely, ranging from 7.2% in Oceania to 25.7% in Africa in a systematic review of studies from 1997–20092; however, a global incidence of 2% was reported by WHO in 20121. PPH is also a significant contributor to severe long-term morbidity4-6. Uterine atony is the most significant cause of PPH; however, other important contributing factors include trauma (lacerations or ruptured uterus), retained placenta, and coagulation disorders. Pre-existing anemia can also aggravate the clinical consequences of PPH7. One of the most prominent breakthroughs in the prevention of PPH was active management of the third stage of labor (AMTSL). AMTSL, first described in 1962, gave the three main components as prophylactic uterotonic drug administration, early cord clamping and cutting, and controlled cord traction8. In 2003, the International Confederation of Midwives and the International Federation of Gynecology and Obstetrics (FIGO) released their first statement on AMTSL9. Thereafter, AMTSL was considered the gold standard intervention for reducing the incidence of PPH3, 10. In the last two decades, much research has been conducted to improve measures to prevent PPH, which culminated in 2012 with the addition of misoprostol to the armamentarium for its prevention1. Additional interventions may help further reduce the incidence of PPH and its associated maternal mortality. We innovated a new technique that can be considered a modification to Amr's maneuver11 for the prevention of PPH. This technique avoids the possibility of increasing uterine prolapse that may result from routine uterine massage or Amr's maneuver. The aim of the present randomized controlled trial is to test the hypothesis that using Khalid's maneuver in conjunction with AMTSL would decrease the incidence of PPH after vaginal delivery more than that achieve
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/01/2020
Actual trial start date
Anticipated date of last follow up 15/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 1010
Actual target sample size (number of participants)
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group active management of third stage of labor routine active management of the third stage of labor only (prophylactic uterotonic drug administration 10 units oxytocin/1000 ml ringer solution, early cord clamping and cutting, and controlled cord traction). during the third stage of labor routine active management of the third stage of labor only (prophylactic uterotonic drug administration 10 units oxytocin/1000 ml ringer solution, early cord clamping and cutting, and controlled cord traction). 505 Active-Treatment of Control Group
Experimental Group uterine traction group The maneuver entails upward traction on the uterus for 3 minutes. Adequate traction will be ensured as the cervix reaches up to the ischial spine. together with active management of the third stage of labor during the third stage of labor The maneuver entails upward traction on the uterus for 3 minutes. Adequate traction will be ensured as the cervix reaches up to the ischial spine. together with active management of the third stage of labor 505
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a) all patients having vaginal delivery, b) aged 18- 40 years, c) singleton pregnancy, d) vertex presentation, and e) full term pregnancy. Patients high risk for PPH including a) patients with anemia Hb<8 gm./dl, b) previous history of PPH, c) preterm birth, and d) history of bleeding disorders. Adult: 19 Year-44 Year 19 Year(s) 44 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
Yes 25/11/2019 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure was the occurrence of PPH (>500 mL blood loss) within the first 6 hours of delivery in both groups. 6 hours after delivery
Secondary Outcome Secondary outcome measures will be amount of blood loss, need for blood transfusion, need for additional uterotonic, and changes in hematocrit and hemoglobin levels in both groups. Women’s discomfort caused by the maneuver will be evaluated. 6 hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
khaled ahmed atwa ring road kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
khaled Ahmed Atwa ring road kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled atwa kh_atwa@hotmail.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Scientific Enquiries khaled atwa kh_atwa@hotmail.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data will be shared through the publication and after approval of our research ethics committee Study Protocol after the end of the trial after approval of our research ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information