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

NCT02680938 | Unknown Phase 1

• 1 other identifier: gyn-057
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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.

  more than 30 minutes, we will do manual separation of placenta

Secondary Outcomes (1)

• Hb difference before and 12 h after delivery.

  before labor and after 12 hours after delievery

Study Arms (2)

oxytocin group

ACTIVE COMPARATOR

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

control group

PLACEBO COMPARATOR

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

Interventions

oxytocin DRUG

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.

Also known as: syntocinon

oxytocin group

saline DRUG

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.

Also known as: placebo

control group

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

kareem Sami mostafa

Cairo, Cairo Governorate, 113311, Egypt

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• kareem S mostafa

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

kareem S mostafa

CONTACT

01288102018; dockimo1@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer assistant

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 12, 2016
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 2, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)