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Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery

Primary Purpose

Postpartum Hemorrhage

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
oxytocin
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Multiparous women (had previous one, up to four deliveries)
  2. Term pregnancy (37 completed weeks at least).
  3. Singleton viable cephalic pregnancy.
  4. Vaginal delivery.

Exclusion Criteria:

  1. Primigravida.(first pregnancy)
  2. Grand multiparous. (had previous 5 or more deliveries)
  3. Maternal illness (involving pregnancy induced condition; PIH,GDM or chronic medical condition; hypertension, cardiac , renal problems)
  4. Previous cesarean section, uterine surgery.
  5. Patients with bleeding tendency.
  6. Previous history of Ante-partum hemorrhage.
  7. Previous history of postpartum hemorrhage.
  8. Abnormal site of the placenta (detected by ultrasound)
  9. Macrosomic baby (EFW more than 4000 gm estimated clinically or by ultrasound)
  10. polyhydramnios.(detected by ultrasound)
  11. Multiple gestation.
  12. Chorioamnionitis.
  13. Suspected fetal problem(anomaly, distress)
  14. Instrumental delivery.
  15. Multiple or deep vaginal tears that compromise the estimation of uterine blood loss.
  16. Cesarean delivery

Sites / Locations

  • Ain Shams University Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

oxytocin before placental delivery

oxytocin after placental delivery

Arm Description

patients who will receive 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly at delivery of anterior shoulder of the fetus and an identical placebo injection (normal saline, NACL 0.9%) intramuscularly following delivery of the placenta.

patients who will receive placebo injection (normal saline, NACL 0.9%) intramuscularly at delivery of anterior shoulder of the fetus and 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly following delivery of the placenta.(opposite medication sequence)

Outcomes

Primary Outcome Measures

blood loss in vaginal delivery

Secondary Outcome Measures

primary postpartum hemorrhage
changes in hemoglobin and hematocrit
retained placenta
length of 3rd stage of labor
manual removal of the placenta
blood pressure
maternal pain
maternal nausea and vomiting
secondary postpartum hemorrhage
surgical intervention to stop the bleeding

Full Information

First Posted
December 22, 2016
Last Updated
March 13, 2017
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03006380
Brief Title
Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery
Official Title
Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized controlled study to assess the efficacy and safety of the timing of administration of prophylactic oxytocin via intramuscular route (before compared to after placental delivery) on blood loss in vaginal delivery.
Detailed Description
400 patients will be recruited for the study,Informed consent will be obtained from all patients following the research criteria once they are admitted in active labor, but they will be enrolled and randomized only when they reach the second stage of labor (fully dilated cervix) as it will be difficult in this stage to counsel patients. The recruited patients will be subjected to the following: History taking: with particular emphasis on past medical history (especially for bleeding tendency), past obstetric history. Checking vital signs, General and abdominal examination. laboratory investigations: complete blood count (CBC) Findings of the initial obstetric evaluation follow up, labor duration and the need for oxytocin augmentation will be recorded through a partogram. All deliveries will be attended by a senior resident in the hospital. Included patients will receive the medication according to randomization tables. After allocation, patients will be excluded only if they required cesarean section, instrumental delivery or had multiple or deep vaginal tears that compromise estimation of uterine blood loss. All patients will undergo gentle traction to the umbilical cord while providing counter traction against the uterine fundus after signs of placental separation; appearance of bleeding, elongation of the cord. All patients will undergo cord clamping and cutting within 30 seconds of delivery. All patients will undergo uterine massage for 30 seconds after placental delivery. Vital signs (blood pressure and pulse) will be checked 15 minutes, 1 hour and 6 hours after placental delivery. CBC will be collected 6 hours after delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oxytocin before placental delivery
Arm Type
Experimental
Arm Description
patients who will receive 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly at delivery of anterior shoulder of the fetus and an identical placebo injection (normal saline, NACL 0.9%) intramuscularly following delivery of the placenta.
Arm Title
oxytocin after placental delivery
Arm Type
Experimental
Arm Description
patients who will receive placebo injection (normal saline, NACL 0.9%) intramuscularly at delivery of anterior shoulder of the fetus and 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly following delivery of the placenta.(opposite medication sequence)
Intervention Type
Drug
Intervention Name(s)
oxytocin
Other Intervention Name(s)
Syntocinon®, NOVARTIS, Egypt
Intervention Description
Ecbolic used to reduce blood loss
Primary Outcome Measure Information:
Title
blood loss in vaginal delivery
Time Frame
blood loss in the third stage of labor (Up to 60 min after delivery of the baby)
Secondary Outcome Measure Information:
Title
primary postpartum hemorrhage
Time Frame
within 24 hours after delivery
Title
changes in hemoglobin and hematocrit
Time Frame
before delivery and after 6 hours
Title
retained placenta
Time Frame
more than 30 minutes after delivery
Title
length of 3rd stage of labor
Time Frame
Up to 60 min from delivery of baby till delivery of placenta
Title
manual removal of the placenta
Time Frame
if not separated after 30 minutes from delivery
Title
blood pressure
Time Frame
to be measured before delivery after 15 minutes,1 hour,6 hours
Title
maternal pain
Time Frame
during third stage of labor
Title
maternal nausea and vomiting
Time Frame
during 3rd stage of labor
Title
secondary postpartum hemorrhage
Time Frame
after 24 hours and before 6 weeks from delivery
Title
surgical intervention to stop the bleeding
Time Frame
within 24 hours after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Multiparous women (had previous one, up to four deliveries) Term pregnancy (37 completed weeks at least). Singleton viable cephalic pregnancy. Vaginal delivery. Exclusion Criteria: Primigravida.(first pregnancy) Grand multiparous. (had previous 5 or more deliveries) Maternal illness (involving pregnancy induced condition; PIH,GDM or chronic medical condition; hypertension, cardiac , renal problems) Previous cesarean section, uterine surgery. Patients with bleeding tendency. Previous history of Ante-partum hemorrhage. Previous history of postpartum hemorrhage. Abnormal site of the placenta (detected by ultrasound) Macrosomic baby (EFW more than 4000 gm estimated clinically or by ultrasound) polyhydramnios.(detected by ultrasound) Multiple gestation. Chorioamnionitis. Suspected fetal problem(anomaly, distress) Instrumental delivery. Multiple or deep vaginal tears that compromise the estimation of uterine blood loss. Cesarean delivery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reham Marie, MRCOG
Phone
+201212977339
Email
rehamfarghal84@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Yehia, MD, MRCOG
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr Yehia, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery

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