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Cervical Traction vs. Active Management of 3rd Stage of Labor

Primary Purpose

Post Partum Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Oxytocin
Oxytocin
cervical traction
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Partum Hemorrhage

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

singleton pregnancy full term pregnancy ( gestational age 37 - 42 weeks).

Exclusion Criteria:

  • twin pregnancy, preterm labor <36 weeks, fetal macrosomia, any case with bleeding tendency e.g: haemorrhagic diseases and cases with risk of postpartum haemorrhage as: Peripartun hemorrhage ( placenta previa or placental abruption), anemia or hypertension

Sites / Locations

  • Kasr Alainy medical schoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cervical traction

Active management

Arm Description

sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus

administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)

Outcomes

Primary Outcome Measures

occurrence of postpartum hemorrhage
blood loss more than 500 ml

Secondary Outcome Measures

Full Information

First Posted
July 10, 2020
Last Updated
February 5, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04747015
Brief Title
Cervical Traction vs. Active Management of 3rd Stage of Labor
Official Title
A Comparative Study Between Cervical Traction and Active Management of 3rd Stage of Labor in Prevention of Postpartum Hemorrhage After Vaginal Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
306 patients will be divided randomly in to 2 GROUPS: control group: 153 patients will receive Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby for both groups in prevention of postpartum haemorrhage,followed by active management of the third stage of labor by administration of oxytocin 5 IU units IM and waiting for signs of placental separation then controlled cord traction (CCT) to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver) study group:156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin is stopped and cervical traction (Amr maneuver )is applied. In the maneuver,sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus. Meanwhile (CCT ) is avoided and watchful waiting for signs of placental separartion till 90 seconds end. Massage is not employed but the fundus is frequently palpaple to insure it doesnot become atonic and filled with blood from placenta separation. In cases whom placental separation did not occur within the 90 seconds, we removed the ovum forceps and waited for 30 min for the placental separation .
Detailed Description
The patients were divided randomly in to 2 GROUPS: control group: 153 patients received Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby according to the WHO recommendation for both groups in prevention of postpartum haemorrhage,followed by active management of the third stage of labor by administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver) study group:156 patients received Oxytocin 10 IU I.V shot at the time of delivery of the of the anterior shoulder of the baby according to the WHO recommendation .Then oxytocin is stopped and cervical traction (Amr maneuver )is applied. In the maneuver,sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus. Meanwhile (CCT ) is avoided and watchful waiting for signs of placental separartion till 90 seconds end. Massage is not employed but the fundus is frequently palpaple to insure it doesnot become atonic and filled with blood from placenta separation. In cases whom placental separation did not occur within the 90 seconds, we removed the ovum forceps and waited for 30 min for the placental separation .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
306 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cervical traction
Arm Type
Active Comparator
Arm Description
sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus
Arm Title
Active management
Arm Type
Active Comparator
Arm Description
administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Routine oxytocin
Intervention Description
Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby according to the WHO recommendation
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Active management
Intervention Description
5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)
Intervention Type
Procedure
Intervention Name(s)
cervical traction
Other Intervention Name(s)
Amr maneuver
Intervention Description
sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus. Meanwhile (CCT ) is avoided and watchful waiting for signs of placental separartion till 90 seconds end
Primary Outcome Measure Information:
Title
occurrence of postpartum hemorrhage
Description
blood loss more than 500 ml
Time Frame
24 hours after delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: singleton pregnancy full term pregnancy ( gestational age 37 - 42 weeks). Exclusion Criteria: twin pregnancy, preterm labor <36 weeks, fetal macrosomia, any case with bleeding tendency e.g: haemorrhagic diseases and cases with risk of postpartum haemorrhage as: Peripartun hemorrhage ( placenta previa or placental abruption), anemia or hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
+201005227404
Email
prof.ahmedmaged@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Abdelhafez, MD
Phone
+201001845356
Email
drali1998@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Cervical Traction vs. Active Management of 3rd Stage of Labor

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