Intraumbilical Oxytocin Versus Placental Cord Drainage in the Management of 3rd Stage of Labor

NCT03395730 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: ppsi
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effectiveness of intraumbilical oxytocin and placental cord drainage in the management of third stage of labor. Does the use of intraumbilical vein oxytocin injection or the use of Placental cord drainage can cause a reduction of blood loss, Hb level drop, the length of the third stage of labor and the incidence of manual removal of the retained placenta during the third stage of labor in pregnant women after delivery of the infant?

Conditions

Postpartum Haemorrhage With Retained Placenta

Outcome Measures

Primary Outcomes (1)

• Duration of the third stage of labor.

  Duration of placental expulsion from the uterus after delivery of the fetus. by the use of a stop watch to calculate the time in minutes and seconds passing starting from the delivery of the baby till delivery of the placenta outside the the vagina. To compare How long does the 3rd stage of labor persist with each intervention (in minutes and seconds).

  5-15 minutes

Secondary Outcomes (3)

• Retained placenta

  >30 minutes

• the Need for manual removal of placenta

  > 30 minutes

• the drop in hemoglobin in gm/dl

  after 2 hours

Study Arms (3)

• Group (A) "Study Group 1":

EXPERIMENTAL

In the labor room women in Group A (n = 50): * Clamping and cutting the placental cord after delivery of the baby. * Immediate intraumbilical vein injection of Oxytocin (Syntocinon®) 20 units diluted in 20 ml of 0.9% saline solution

Drug: Intraumbilical vein injection oxytocin

• Group (B) "Study Group 2":

EXPERIMENTAL

In the labor room women in Group B (n = 50): * Clamping and cutting the placental cord after delivery of the baby. * Immediate unclamping of the maternal side, allowing the blood to drain freely for a duration of three minutes.

Procedure: placental cord drainage

• Group (C) "Control Group":

ACTIVE COMPARATOR

In the labor room women in Group C (n = 50): * Clamping and cutting the placental cord after 2 minutes of delivery of the baby. * Placenta will be delivered spontaneously after appearance of clinical signs of placental separation

Procedure: Expectant managment of 3rd stage of labour

Interventions

Intraumbilical vein injection oxytocin DRUG

intraumbilical vein injection of oxytocin 20 units diluted in 20 ml of 0.9% saline solution immediately after delivery of the baby, clamping and cutting the cord.

• Group (A) "Study Group 1":

placental cord drainage PROCEDURE

placental cor drainage immediately after delivery. This scenario will include placental cord clamping and cutting after delivery of the baby followed by immediately unclamping of the maternal side, allowing the blood to drain freely for a duration of three minutes.

• Group (B) "Study Group 2":

Expectant managment of 3rd stage of labour PROCEDURE

Placenta will be delivered spontaneously after appearance of clinical signs of placental separation, which include strong uterine contraction, vaginal bleeding, and descending of umbilical cord through the vulva. This scenario will include placental cord clamping and cutting after 2 minutes of delivery of the baby.

• Group (C) "Control Group":

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women between 18-35 years of age with normal pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between 18-35 years of age with normal pregnancy.
• A singleton fetus at a gestational age of 37 - 42 weeks in a cephalic presentation.
• Neonatal birth weight of 2500 to 4500 grams.

You may not qualify if:

• Medical disorders and hypertensive disorders of pregnancy.
• Intrauterine fetal death.
• Known or suspected fetal anomalies.
• Oxytocin induction or augmented cases.
• Obstetrical complications (bleeding, premature rupture of membranes).
• Previous CS or Previous Myomectomy.

Sponsors & Collaborators

• Eslam Mohammed Abbas: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, 11311, Egypt

RECRUITING

Study Officials

• Tamer F Borg, MD

  Ain Shams University

  STUDY DIRECTOR

• Bassem I Ali, MD

  Ain Shams University

  STUDY DIRECTOR

• Islam M Abbas, MBBch

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Islam M Abbas, MBBch

CONTACT

00201025864906; dr.eslamabbas@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomization will be based on the sequence generation created by computer and the randomization tables will be kept with the study supervisor. Consenting patients fulfilling inclusion criteria will be randomized into one of the following 3 groups. Randomized allocation will be kept in opaque sealed envelopes, with enrollment numbers written on the envelopes. The envelopes will contain a card on with the designated study group will be written. After enrollment of the patients in the study, the envelopes marked with study number will be unsealed and the patients allocated to either groups
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physician

Model Details: The present study will be conducted on 150 women recruited from the delivery ward of our hospital after they had received information on the purpose and course of the study from the medical investigator and had provided the written consent during routine prenatal visits , they will be randomly divided into: * Group (A) "Study Group 1": (n = 50) * Group (B) "Study Group 2": (n = 50) * Group (C) "Control Group": (n = 50)

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 10, 2018
• Study Start: September 30, 2017
• Primary Completion: January 15, 2018
• Study Completion: January 30, 2018
• Last Updated: January 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)