Postpartum Uterotonic Administration

Postpartum Bleeding Clinical Trial

Official title:

The Effect of the Timing of Uterotonic Administration in the Third Stage of Labour on Postpartum Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02495272
• Other study ID #: Kanuni-Bagcilar
• Status: Recruiting
• Phase: N/A
• First received: April 9, 2015
• Last updated: July 8, 2015
• Start date: June 2014
• Est. completion date: January 2016

Study information

• Verified date: July 2015
• Source: Bagcilar Training and Research Hospital
• Contact: Dogukan Yildirim, MD
• Phone: +905063284383
• Email: dogukanyildirim[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postpartum Bleeding
• Postpartum Hemorrhage

Intervention

Drug:
• Oxytocin
Oxytocin 10IU Administered intramuscularly.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Teaching and Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital	Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum blood loss	Quantitative collection of blood loss.	Participants will be followed for the duration of hospital stay, an expected average of 24 hour	Yes
Primary	Postpartum blood loss >500cc	Number of participants whose blood loss is higher than 500cc.	Participants will be followed for the duration of hospital stay, an expected average of 24 hour	Yes
Secondary	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.	Participants will be followed for the duration of hospital stay, an expected average of 24 hour	Yes
Secondary	Postpartum transfusion		Participants will be followed for the duration of hospital stay, an expected average of 24 hour.	Yes
Secondary	Manual removal of the placenta.		At first hour after delivery of the fetus	Yes
Secondary	Duration of the third stage of labour.		Participants will be followed for the duration of labor unit stay, an expected average of one hour	Yes
Secondary	Drop in the hemoglobin and hematocrit levels		At the 24th hour,postpartum	Yes