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

March 1, 2016 updated by: kareem Sami mostafa, Ain Shams University

Prophylactic Use of Intraumbilical Vein Oxytocin Injection in The Management of Third Stage of Labor A Randomized Controlled Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

    1. The duration of the third stage of labor by stopwatch.
    2. Hemoglobin (Hb) difference before and 12 h after delivery.
    3. 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.
    4. Estimate blood loss by Allowable Blood Loss (ABL) (Miller 2000)

Study Type

Interventional

Enrollment (Anticipated)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oxytocin 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.
Drug: oxytocin

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:

  1. The duration of the third stage of labor by stopwatch.
  2. Hemoglobin (Hb) difference before and 12 h after delivery.
  3. 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.
Other Names:
  • syntocinon
Placebo Comparator: 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.
Drug: saline

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:

  1. The duration of the third stage of labor by stopwatch.
  2. Hemoglobin (Hb) difference before and 12 h after delivery.
  3. 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.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the third stage of labor.
Time Frame: more than 30 minutes, we will do manual separation of placenta
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.
more than 30 minutes, we will do manual separation of placenta

Secondary Outcome Measures

Outcome Measure
Time Frame
Hb difference before and 12 h after delivery.
Time Frame: before labor and after 12 hours after delievery
before labor and after 12 hours after delievery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: kareem S mostafa, ain shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimate)

February 12, 2016

Study Record Updates

Last Update Posted (Estimate)

March 2, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gyn-057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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