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NCT04401839 Clinical Trial

Amr Maneuver for Prevention of Postpartum Hemorrhage

Post Partum Hemorrhage Clinical Trial

Official title:
Amr Maneuver for Prevention of Postpartum Hemorrhage After Vaginal Delivery in Term Women

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04401839
Other study ID # 59
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 31, 2020
Est. completion date September 2021

Study information
Verified date February 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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 .

Recruitment information / eligibility
Status Recruiting
Enrollment 306
Est. completion date September 2021
Est. primary completion date August 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - women who candidate for vaginal delivery at casualty department singleton fetus full term pregnancy ( gestational age of more than 37 weeks). Exclusion Criteria: - fetal macrosomia, any case with bleeding tendency e.g: haemorrhagic diseases cases with risk of postpartum haemorrhage as: Peripartun hemorrhage ( placenta previa or placental abruption), anemia or hypertension.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oxytocin IV shot
Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby
• Oxytocin IV drip
administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation
Procedure:
• Amr maneuver
sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds

Locations
Country Name City State
Egypt Kasr Alainy medical school Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary postpartum hemorrhage blood loss more than 500 cc after delivery 24 hours after delivery
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