Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
Primary Purpose
Postpartum Haemorrhage
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
bimanual uterine compression
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Haemorrhage focused on measuring Uterine massage, vaginal birth, postpartum haemorrhage
Eligibility Criteria
Inclusion Criteria:
- Gestational age more than 28 weeks the gestational age was determined based upon the date of the first day of last normal menstrual period and confirmed by ultrasound scan during the 1st trimester
Women at high risk for primary atonic postpartum hemorrhage
- Over distended uterus
- Large fetus
- Multiple fetuses
- Hydramnios
- Distension with clots accidental hemorrhage
- Exhausted myometrium
- Prolonged labor
- Oxytocin or prostaglandin stimulation
- Chorioamnionitis
- Previous uterine atony
- Placenta previa
- Marked anemia
Exclusion Criteria:
- Cervical tear
- extensive birth canal tear
- Postpartum hemorrhage
- Retained placenta
- Coagulopathy
- Chronic medical illness hepatic renal
- Pregnancy induced hypertension PIH
- Refusal to participate in the study
Sites / Locations
- Benha univesity hospital and afhsaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Group A
Group B
Arm Description
bimanual uterine compression immediately after delivery of placenta for 5 minutes in 260 women
no intervention (260 women).
Outcomes
Primary Outcome Measures
Blood loss 500 ml or more after enrolment
estimating blood loss from vagina
Secondary Outcome Measures
Blood loss 1000 ml or more after enrolment
estimating blood loss by collecting it
Use of additional uterotonics or other procedures
giving drugs IV
Blood transfusion
giving how many units of PRBCS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02136719
Brief Title
Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
Official Title
Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
the investigators aim to compare bimanual uterine compression immediately after delivery of the placenta for 5 minutes versus no intervention for the prevention of postpartum hemorrhage in Women at high risk for primary atonic postpartum hemorrhage. The primary outcome is postpartum haemorrhage (blood loss of ≥ 500 ml) while the Secondary outcomes include use of additional uterotonics and need for blood transfusion.
Detailed Description
the investigators conduct a prospective non- randomized study at Department of Obstetrics and Gynecology, Benha University Hospital, since April 2014 till May 2016, after approval of the study protocol by the Local Ethical Committee. A written informed consent is obtained from eligible women before induction or at early stage of labour.
Women with singleton pregnancies of more than 28 weeks' gestation who are admitted to hospital and candidates for vaginal delivery are eligible for the study .Gestational age more than 28 weeks the gestational age is determined based upon the date of the first day of last normal menstrual period and confirmed by ultrasound scan during the 1st trimester.
The patients (520) are divided into two groups, Group A (260) receive bimanual uterine compression immediately after delivery of the placenta for 5 minutes while Group B (260) receive no intervention.
The third stage of labour was managed as usual by clamping and cutting of umbilical cord, waiting for signs of placental separation and delivering the placenta by controlled cord traction.
Duration of the 3rd stage of labour is calculated. Patients are kept in labor room under observation for a period of 1 h.
Measurement of blood loss by a clean plastic lined absorbent drape placed under the woman's buttocks to collect all the blood lost after delivery of the baby and drainage of the amniotic fluid. The drape is changed as many times as needed. The woman stays on the drape or asked to wear a pad over the next 60 minutes. In the case of severe haemorrhage, the investigators follow the usual guidelines for management of postpartum haemorrhage, and the supplemental treatment registered. All drapes and pads are weighed on an electronic scale and the known dry weight of the linen is subtracted. As 1 ml of blood weighs close to 1 g, the balance in grams is assumed to be the total blood loss in ml.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Haemorrhage
Keywords
Uterine massage, vaginal birth, postpartum haemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
520 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
bimanual uterine compression immediately after delivery of placenta for 5 minutes in 260 women
Arm Title
Group B
Arm Type
No Intervention
Arm Description
no intervention (260 women).
Intervention Type
Procedure
Intervention Name(s)
bimanual uterine compression
Intervention Description
bimanual uterine compression immediately after delivery of placenta for 5 minutes
Primary Outcome Measure Information:
Title
Blood loss 500 ml or more after enrolment
Description
estimating blood loss from vagina
Time Frame
60 minutes after enrolment
Secondary Outcome Measure Information:
Title
Blood loss 1000 ml or more after enrolment
Description
estimating blood loss by collecting it
Time Frame
(up to 30 and 60 minutes) after enrolment
Title
Use of additional uterotonics or other procedures
Description
giving drugs IV
Time Frame
60 minutes
Title
Blood transfusion
Description
giving how many units of PRBCS
Time Frame
60 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age more than 28 weeks the gestational age was determined based upon the date of the first day of last normal menstrual period and confirmed by ultrasound scan during the 1st trimester
Women at high risk for primary atonic postpartum hemorrhage
Over distended uterus
Large fetus
Multiple fetuses
Hydramnios
Distension with clots accidental hemorrhage
Exhausted myometrium
Prolonged labor
Oxytocin or prostaglandin stimulation
Chorioamnionitis
Previous uterine atony
Placenta previa
Marked anemia
Exclusion Criteria:
Cervical tear
extensive birth canal tear
Postpartum hemorrhage
Retained placenta
Coagulopathy
Chronic medical illness hepatic renal
Pregnancy induced hypertension PIH
Refusal to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
khalid ibrahim, MD
Email
dr.khalidkhader77@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
ibrahim zweel
Email
dribrahimzweel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ibrahim zweel
Organizational Affiliation
Department of Obstetrics and Gynecology,AFHSA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benha univesity hospital and afhsa
City
Banhā
State/Province
El Qualyobia
ZIP/Postal Code
13518
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
khalid mohamed
Phone
201281469651
Email
dr.khalidkhader77@yahoo.com
First Name & Middle Initial & Last Name & Degree
ibrahim zweel, MD
12. IPD Sharing Statement
Learn more about this trial
Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery
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