Postpartum Uterotonic Administration

Not Applicable

• Conditions: Postpartum Bleeding
• Interventions: Drug: Oxytocin

• Registration Number: NCT02495272
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-04-09
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-08
• Last Update Submitted: 2015-07-08
• Study First Posted: 2015-07-13
• Last Update Posted: 2015-07-13
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Oxytocin	Oxytocin 10IU im was administered after placental delivery
Study Group	Oxytocin	Oxytocin 10IU im was administered after the anterior shoulder could be seen.

Primary Outcome Measures

Name	Time	Method
Postpartum blood loss	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	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

Name	Time	Method
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	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.
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

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Teaching and Research Hospital; 🇹🇷 Istanbul, Turkey