Prophylactic Use of Intraumbilical Vein Oxytocin Injection in The Management of Third Stage of Labor A Randomized Controlled Study
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Ain Shams University
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Duration of the third stage of labor.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 14 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •36 to 42 weeks gestational age.
- •Single alive fetus with cephalic presentation.
- •Parity 1 to
- •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
Arms & Interventions
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.
Intervention: oxytocin (Drug)
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.
Intervention: saline (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Hb difference before and 12 h after delivery.(before labor and after 12 hours after delievery)
Investigators
kareem Sami mostafa
lecturer assistant
Ain Shams University