The Effect of the Timing of Uterotonic Administration in the Third Stage of Labour on Postpartum Hemorrhage
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Postpartum blood loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control Group
Oxytocin 10IU im was administered after placental delivery
Intervention: Oxytocin (Drug)
Study Group
Oxytocin 10IU im was administered after the anterior shoulder could be seen.
Intervention: Oxytocin (Drug)
Outcomes
Primary Outcomes
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.
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 Outcomes
- Duration of the third stage of labour.(Participants will be followed for the duration of labor unit stay, an expected average of one hour)
- Need for additional uterotonics(Participants will be followed for the duration of hospital stay, an expected average of 24 hour)
- Manual removal of the placenta.(At first hour after delivery of the fetus)
- Postpartum transfusion(Participants will be followed for the duration of hospital stay, an expected average of 24 hour.)
- Drop in the hemoglobin and hematocrit levels(At the 24th hour,postpartum)
Investigators
Eser Sefik Ozyurek
MD
Bagcilar Training and Research Hospital