Clinical trial NCT02495272: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Bleeding
Keywords: Postpartum hemorrhage
Third stage of labour
Oxytocin
Uterotonics
Active management of third stage of labour
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Kanuni Sultan Suleyman Training and Research Hospital
First posted: 2015-07-13
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Postpartum blood loss
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour
measure: Postpartum blood loss >500cc
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour
Secondary outcomes:
measure: Need for additional uterotonics
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour
measure: Postpartum transfusion
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 24 hour.
measure: Manual removal of the placenta.
timeFrame: At first hour after delivery of the fetus
measure: Duration of the third stage of labour.
timeFrame: Participants will be followed for the duration of labor unit stay, an expected average of one hour
measure: Drop in the hemoglobin and hematocrit levels
timeFrame: At the 24th hour,postpartum
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Teaching and Research Hospital
Study officials:
affiliation: Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
name: Burak Ozkose, MD
role: STUDY_CHAIR
affiliation: Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
name: Dogukan Yildirim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bagcilar Training and Research Hospital
name: Eser S Ozyurek, MD
role: STUDY_CHAIR
affiliation: Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul
name: Batuhan Ustun, MD
role: STUDY_CHAIR
References:
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.