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Postpartum Uterotonic Administration

Primary Purpose

Postpartum Bleeding

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
Bagcilar Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Bleeding focused on measuring Postpartum hemorrhage, Third stage of labour, Oxytocin, Uterotonics, Active management of third stage of labour

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Cephalic presentation
  • Singleton pregnancy
  • Gestational age >35 weeks,
  • In active labour.
  • Expected fetal birth weight 2500-4500 grams.

Exclusion Criteria:

  • Acute Fetal Distress
  • Conversion to abdominal delivery
  • Persistent high blood pressure (>140/90mmHg)
  • Placenta Previa
  • Ablatio placenta
  • Previous C-Section
  • Uterine scar
  • Postpartum hemorrhage in previous pregnancies.
  • Hydramnios
  • Maternal infection
  • Forceps/Vacuum Assisted deliveries
  • Abnormal placentation ( Placenta accreta, increta or percreta)
  • Coagulation Defects
  • Hemoglobin < 8g/dl

Sites / Locations

  • Kanuni Sultan Suleyman Teaching and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Study Group

Arm Description

Oxytocin 10IU im was administered after placental delivery

Oxytocin 10IU im was administered after the anterior shoulder could be seen.

Outcomes

Primary Outcome Measures

Postpartum blood loss
Quantitative collection of blood loss.
Postpartum blood loss >500cc
Number of participants whose blood loss is higher than 500cc.

Secondary Outcome Measures

Need for additional uterotonics
Additional uterotonics (Oxytocin 10IU; Cytotec tb Rectal and/or vaginal) were administered if postpartum blood loss >500ml OR uterine atony was observed OR sudden excessive hemorrhage was encountered.
Postpartum transfusion
Manual removal of the placenta.
Duration of the third stage of labour.
Drop in the hemoglobin and hematocrit levels

Full Information

First Posted
April 9, 2015
Last Updated
July 8, 2015
Sponsor
Bagcilar Training and Research Hospital
Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02495272
Brief Title
Postpartum Uterotonic Administration
Official Title
The Effect of the Timing of Uterotonic Administration in the Third Stage of Labour on Postpartum Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bagcilar Training and Research Hospital
Collaborators
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are planning to determine the effect of the timing of oxytocin administration on the amount of blood loss, necessity for additional medical or surgical interventions.
Detailed Description
The investigators are studying the effects of the timing of intramuscular oxytocin administration in the third stage of labour. The investigators are measuring the postpartum blood loss: quantitatively in the postpartum 1st hour and indirectly by the decrease in the hemoglobin-haematocrit levels in the postpartum 24th hour. The investigators are monitoring the length of the third stage of labour, and the need for extra uterotonics and/or surgical interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Bleeding
Keywords
Postpartum hemorrhage, Third stage of labour, Oxytocin, Uterotonics, Active management of third stage of labour

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Oxytocin 10IU im was administered after placental delivery
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Oxytocin 10IU im was administered after the anterior shoulder could be seen.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
PostuitrinFort Amp I.E.Ulagay
Intervention Description
Oxytocin 10IU Administered intramuscularly.
Primary Outcome Measure Information:
Title
Postpartum blood loss
Description
Quantitative collection of blood loss.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 24 hour
Title
Postpartum blood loss >500cc
Description
Number of participants whose blood loss is higher than 500cc.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 24 hour
Secondary Outcome Measure Information:
Title
Need for additional uterotonics
Description
Additional uterotonics (Oxytocin 10IU; Cytotec tb Rectal and/or vaginal) were administered if postpartum blood loss >500ml OR uterine atony was observed OR sudden excessive hemorrhage was encountered.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 24 hour
Title
Postpartum transfusion
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 24 hour.
Title
Manual removal of the placenta.
Time Frame
At first hour after delivery of the fetus
Title
Duration of the third stage of labour.
Time Frame
Participants will be followed for the duration of labor unit stay, an expected average of one hour
Title
Drop in the hemoglobin and hematocrit levels
Time Frame
At the 24th hour,postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cephalic presentation Singleton pregnancy Gestational age >35 weeks, In active labour. Expected fetal birth weight 2500-4500 grams. Exclusion Criteria: Acute Fetal Distress Conversion to abdominal delivery Persistent high blood pressure (>140/90mmHg) Placenta Previa Ablatio placenta Previous C-Section Uterine scar Postpartum hemorrhage in previous pregnancies. Hydramnios Maternal infection Forceps/Vacuum Assisted deliveries Abnormal placentation ( Placenta accreta, increta or percreta) Coagulation Defects Hemoglobin < 8g/dl
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dogukan Yildirim, MD
Phone
+905063284383
Email
dogukanyildirim@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eser S Ozyurek, MD
Phone
+905309322345
Email
eozyurek@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burak Ozkose, MD
Organizational Affiliation
Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dogukan Yildirim, MD
Organizational Affiliation
Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eser S Ozyurek, MD
Organizational Affiliation
Bagcilar Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Batuhan Ustun, MD
Organizational Affiliation
Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
Official's Role
Study Chair
Facility Information:
Facility Name
Kanuni Sultan Suleyman Teaching and Research Hospital
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dogukan Yıldırım, MD
Phone
+905063284383
Email
dogukanyildirim@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25108586
Citation
Oguz Orhan E, Dilbaz B, Aksakal SE, Altinbas S, Erkaya S. Prospective randomized trial of oxytocin administration for active management of the third stage of labor. Int J Gynaecol Obstet. 2014 Nov;127(2):175-9. doi: 10.1016/j.ijgo.2014.05.022. Epub 2014 Jul 17.
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Postpartum Uterotonic Administration

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