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

NCT02680938 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2016-03-02

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage

Interventions

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.

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • kareem S mostafa · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-02-29
Completion
2016-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02680938 on ClinicalTrials.gov