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Prophylactic Use of Intraumbilical Vein Oxytocin Injection in The Management of Third Stage of Labor

Primary Purpose

Postpartum Hemorrhage

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
oxytocin
saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Postpartum Hemorrhage

Eligibility Criteria

14 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. 36 to 42 weeks gestational age.
  2. Single alive fetus with cephalic presentation.
  3. Parity 1 to 3.
  4. Normal vaginal delivery.

Exclusion Criteria:

  1. Placenta Previa.
  2. Placental Abruption .
  3. Prolonged Labor ( > 20 h )
  4. History of Postpartum Hemorrhage or Antepartum Hemorrhage.
  5. History of Cesarean delivery or any uterine scar .
  6. Polyhydramnios .
  7. Known uterine anomalies.
  8. Coagulation disorders.
  9. Abnormal placental adhesion.
  10. Forceps or Vacuum delivery.
  11. Chorioamninitis.
  12. Multiple Gestations.
  13. Accelerated Labor (< 3 h ).
  14. Painless Labor with Epidural Anaethesia

Sites / Locations

  • kareem Sami mostafaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

oxytocin group

control group

Arm Description

10 units of oxytocin will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.

1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.

Outcomes

Primary Outcome Measures

Duration of the third stage of labor.
For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded.

Secondary Outcome Measures

Hb difference before and 12 h after delivery.

Full Information

First Posted
February 4, 2016
Last Updated
March 1, 2016
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02680938
Brief Title
Prophylactic Use of Intraumbilical Vein Oxytocin Injection in The Management of Third Stage of Labor
Official Title
Prophylactic Use of Intraumbilical Vein Oxytocin Injection in The Management of Third Stage of Labor A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The third stage is the interval between delivery of the infant and delivery of the placenta. This stage averages 10 minutes and is considered prolonged if it lasts longer than 30 minutes, placental separation occurs as a result of continued uterine contractions, continued contractions control blood loss by compression of spiral arteries and also result in migration of the placenta into the lower uterine segment and then through the cervix. The intra-umbilical vein injection of 10 IU of oxytocin is recommended as a first line of treatment for retained placenta. Despite this recommendation, the method has yet to make its way into routine practice, probably because of the lack of a large substantive randomized controlled trial, and lingering doubts over which uterotonic to use and at what dosage. The purpose of this study is to evaluate the effect of intraumbilical vein injection of oxytocin on reducing the duration of the third stage of labor and the need for manual delivery of placenta, ,in addition to reduce blood loss during third and fourth stage of labor and decrease incidence of rtained placenta in comparison with inraumblical injection of normal saline. This is a prospective randomized control trial conducted at Ain Shams University Maternity Hospital. This study included 240 term pregnant women in labor admitted to the labor ward, They were divided into Two groups : Group (A): The experimental group, 10 units of oxytocin will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord. Group (B): The control group, 1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
Detailed Description
This study included 240 term pregnant women in labor admitted to the labor ward, They were divided into Two groups : Group (A): The experimental group, 10 units of oxytocin will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord. Group (B): The control group, 1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord. complete blood count of both groups before and 12 h after delivery. The third stage of labor will be actively managed in the two groups by infusion of 20 IU oxytocin in 1 L Ringer's lactate solution at a rate of 100 mL/min, immediately after delivery of the fetus ( Nankali et al., 2013).. In the control group ( B ) , 1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord. In the experimental group ( A ) , instead of normal saline, 10 IU (1mL) oxytocin will be injected at the same site. We will wait 30 min for the symptoms of placenta delivery (i.e., the uterus became firmer and more globular and was displaced upward, a gush of blood occurred, and the umbilical cord was elongated). Spontaneous delivery of the placenta will be achieved by touching the fundus and applying pressure on the symphysis pubis by a finger and slight traction of the umbilical cord. For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded. The two groups will be compared in the following terms: The duration of the third stage of labor by stopwatch. Hemoglobin (Hb) difference before and 12 h after delivery. The need for manual delivery of the placenta. Manual removal of the placenta will be commonly carried out under general sedation in the operating room, if the placenta will not be delivered 30 min after fetal delivery. Estimate blood loss by Allowable Blood Loss (ABL) (Miller 2000)

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oxytocin group
Arm Type
Active Comparator
Arm Description
10 units of oxytocin will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
1 mL normal saline will be injected into the umbilical vein at the most proximal site to the placenta after clamping and cutting of the umbilical cord.
Intervention Type
Drug
Intervention Name(s)
oxytocin
Other Intervention Name(s)
syntocinon
Intervention Description
For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded. - The two groups will be compared in the following terms: The duration of the third stage of labor by stopwatch. Hemoglobin (Hb) difference before and 12 h after delivery. The need for manual delivery of the placenta. Manual removal of the placenta will be commonly carried out under general sedation in the operating room, if the placenta will not be delivered 30 min after fetal delivery.
Intervention Type
Drug
Intervention Name(s)
saline
Other Intervention Name(s)
placebo
Intervention Description
For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded. - The two groups will be compared in the following terms: The duration of the third stage of labor by stopwatch. Hemoglobin (Hb) difference before and 12 h after delivery. The need for manual delivery of the placenta. Manual removal of the placenta will be commonly carried out under general sedation in the operating room, if the placenta will not be delivered 30 min after fetal delivery.
Primary Outcome Measure Information:
Title
Duration of the third stage of labor.
Description
For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded.
Time Frame
more than 30 minutes, we will do manual separation of placenta
Secondary Outcome Measure Information:
Title
Hb difference before and 12 h after delivery.
Time Frame
before labor and after 12 hours after delievery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 36 to 42 weeks gestational age. Single alive fetus with cephalic presentation. Parity 1 to 3. Normal vaginal delivery. Exclusion Criteria: Placenta Previa. Placental Abruption . Prolonged Labor ( > 20 h ) History of Postpartum Hemorrhage or Antepartum Hemorrhage. History of Cesarean delivery or any uterine scar . Polyhydramnios . Known uterine anomalies. Coagulation disorders. Abnormal placental adhesion. Forceps or Vacuum delivery. Chorioamninitis. Multiple Gestations. Accelerated Labor (< 3 h ). Painless Labor with Epidural Anaethesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kareem S mostafa
Phone
01288102018
Email
dockimo1@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kareem S mostafa
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
kareem Sami mostafa
City
Cairo
ZIP/Postal Code
113311
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
kareem S mostafa
Email
dockimo1@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The aim of the present study was to evaluate the effect of intraumbilical vein oxytocin on reducing the duration of the third stage of labor and the need for manual delivery of placenta, in comparison with normal saline administration

Learn more about this trial

Prophylactic Use of Intraumbilical Vein Oxytocin Injection in The Management of Third Stage of Labor

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