Postpartum Bleeding Clinical Trial
Official title:
The Effect of the Timing of Uterotonic Administration in the Third Stage of Labour on Postpartum Hemorrhage
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Turkey | Kanuni Sultan Suleyman Teaching and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bagcilar Training and Research Hospital | Kanuni Sultan Suleyman Training and Research Hospital |
Turkey,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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Hemcon© Bandage for Postpartum Bleeding Due to the Multiple Vaginal Lacerations
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Completed |
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When and How to Administer Oxytocin for Active Management of Third Stage of Labour
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