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Postpartum Uterotonic Administration

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ClinicalTrials.gov Identifier: NCT02495272
Recruitment Status : Unknown
Verified July 2015 by Eser Sefik Ozyurek, Bagcilar Training and Research Hospital.
Recruitment status was:  Recruiting
First Posted : July 13, 2015
Last Update Posted : July 13, 2015
Sponsor:
Collaborator:
Kanuni Sultan Suleyman Training and Research Hospital
Information provided by (Responsible Party):
Eser Sefik Ozyurek, Bagcilar Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Postpartum Bleeding Drug: Oxytocin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of the Timing of Uterotonic Administration in the Third Stage of Labour on Postpartum Hemorrhage
Study Start Date : June 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Active Comparator: Control Group
Oxytocin 10IU im was administered after placental delivery
Drug: Oxytocin
Oxytocin 10IU Administered intramuscularly.
Other Name: PostuitrinFort Amp I.E.Ulagay

Experimental: Study Group
Oxytocin 10IU im was administered after the anterior shoulder could be seen.
Drug: Oxytocin
Oxytocin 10IU Administered intramuscularly.
Other Name: PostuitrinFort Amp I.E.Ulagay




Primary Outcome Measures :
  1. Postpartum blood loss [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour ]
    Quantitative collection of blood loss.

  2. Postpartum blood loss >500cc [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour ]
    Number of participants whose blood loss is higher than 500cc.


Secondary Outcome Measures :
  1. Need for additional uterotonics [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour ]
    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.

  2. Postpartum transfusion [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour. ]
  3. Manual removal of the placenta. [ Time Frame: At first hour after delivery of the fetus ]
  4. 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 ]
  5. Drop in the hemoglobin and hematocrit levels [ Time Frame: At the 24th hour,postpartum ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495272


Contacts
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Contact: Dogukan Yildirim, MD +905063284383 dogukanyildirim@yahoo.com
Contact: Eser S Ozyurek, MD +905309322345 eozyurek@yahoo.com

Locations
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Turkey
Kanuni Sultan Suleyman Teaching and Research Hospital Recruiting
Istanbul, Turkey, 34303
Contact: Dogukan Yıldırım, MD    +905063284383    dogukanyildirim@yahoo.com   
Sponsors and Collaborators
Bagcilar Training and Research Hospital
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
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Study Chair: Burak Ozkose, MD Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
Principal Investigator: Dogukan Yildirim, MD Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
Study Chair: Eser S Ozyurek, MD Bagcilar Training and Research Hospital
Study Chair: Batuhan Ustun, MD Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul

Publications:
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Responsible Party: Eser Sefik Ozyurek, MD, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02495272     History of Changes
Other Study ID Numbers: Kanuni-Bagcilar
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: July 13, 2015
Last Verified: July 2015

Keywords provided by Eser Sefik Ozyurek, Bagcilar Training and Research Hospital:
Postpartum hemorrhage
Third stage of labour
Oxytocin
Uterotonics
Active management of third stage of labour

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Puerperal Disorders
Uterine Hemorrhage
Hemorrhage
Obstetric Labor Complications
Pregnancy Complications
Pathologic Processes
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs