Intraumbilical Vein Injection of Oxytocin in Routine Practice for Active Management of the Third Stage of Labor

March 25, 2010 updated by: Erzincan Military Hospital

During the first hours that follow the birth of the baby (third and fourth stages of labor), complications are common and can threaten the mother's life. The most common complication is postpartum hemorrhage (PPH), which remains a leading cause of maternal mortality (25.0%) especially in developing countries .Three to five percent of deliveries are complicated by PPH and is 50 times more common in developing countries. Retained placenta is an another complication of third stage of labor. It complicates 0.1-2 % of deliveries . Without prompt treatment, women are at high risk of hemorrhage. At present, treatment is by manual removal of placenta, which needs an operating theatre, a surgeon, and an anaesthetist-facilities that are often unavailable to women in resource-poor settings. As a result, this condition has a case fatality rate of nearly 10% in rural communities.

The length of the third stage of labor, and its subsequent complications depends on a combination of the length of time it takes for placental separation and the ability of the uterine muscle to contract. Principal management of the third stage of labor is aimed at reducing the time of delivery of placenta so minimising serious adverse effects, such as blood loss and retained placenta. Active management of the third stage of labor, which includes prophylactic injection of 10 units of oxytocin within two minutes of birth, early clamping of the umbilical cord and controlled cord traction (CCT), is recommended by WHO for PPH prevention .

Umbilical vein oxytocin injection directs the treatment to the placental bed and uterine wall, resulting in an earlier uterine contraction and placental separation. However, very limited published literature is available, which evaluated the effect of umbilical vein oxytocin injection in routine practices for active management of the third stage of labor. The purpose of this investigation was to find out the beneficial effect of adding intraumbilical vein oxytocin in reducing the blood loss during third and fourth stages of labor, length of third stage of labor, and reduction in the incidence of manual removal of retained placenta.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

412

Phase

  • Phase 3

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

15 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • gestational age between 37 and 42 weeks
  • singleton pregnancy
  • live fetus
  • cephalic presentation
  • neonatal birth weight of 2500-4500 g
  • parity between one and five
  • maternal age < 35 years
  • vaginal birth

Exclusion Criteria:

  • blood pressure ≥ 140/90mmHg
  • placenta previa
  • placental abruption
  • a history of any bleeding during pregnancy
  • a history of curettage
  • cesarean section or any uterine scar
  • a history of postpartum hemorrhage
  • polyhydramnios
  • signs or symptoms of maternal infection
  • known uterine anomalies
  • history of any drug use during labor
  • abnormal placentation)
  • coagulation defects
  • instrumental deliveries
  • hemoglobin concentration < 8 g/dL
  • history of anticoagulant drugs
  • beta-mimetic medications during pregnancy
  • prolongation of the first stage of labor > 15 hours.

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: Prevention
  • Allocation: Randomized
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saline group
Only 30 mL of saline was injected directly in the umbilical vein after clamping. The injection was performed with a 30-mL syringe and an 18-gauge needle around 1 to 2 cm from the introitus. The solution was injected slowly over 1 minute and at the end of the injection, the solution was milked toward the cord insertion.
Drug: Oxytocin
20 IU of oxytocin diluted with 26 ml of saline.The medication was injected directly in the umbilical vein after clamping. The injection was performed with a 30-ml syringe and an 18-gauge needle around 1 to 2 cm from the introitus. The solution was injected slowly over 1 minute, and at the end of the injection, the solution was milked toward the cord insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the amount of blood loss in third and fourth stages of labor
Time Frame: The end of the delivery to 2 hours after birth.
The end of the delivery to 2 hours after birth.

Secondary Outcome Measures

Outcome Measure
Measure Description
duration of the third stage
The duration of the third stage of labor was defined as the time difference (in minutes) between delivery of the infant and delivery of the placenta. The time interval was measured by the nurse attending the delivery and confirmed by the physician using a digital stop clock. The clock was started as soon as baby's body was totally delivered and stopped as soon as the placenta was completely expulsed.

Collaborators and Investigators

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

Sponsor

Erzincan Military Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

March 25, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Estimate)

March 26, 2010

Last Update Submitted That Met QC Criteria

March 25, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07

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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