Postpartum Uterotonic Administration

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postpartum Bleeding

Intervention / Treatment
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* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Oxytocin 10IU im was administered after placental delivery | Drug: Oxytocin<br>* Oxytocin 10IU Administered intramuscularly.<br>* Other names: PostuitrinFort Amp I.E.Ulagay;|
| Experimental: Study Group<br>Oxytocin 10IU im was administered after the anterior shoulder could be seen. | Drug: Oxytocin<br>* Oxytocin 10IU Administered intramuscularly.<br>* Other names: PostuitrinFort Amp I.E.Ulagay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum blood loss | Quantitative collection of blood loss. | Participants will be followed for the duration of hospital stay, an expected average of 24 hour | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Postpartum transfusion |  | 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 | 
| Duration of the third stage of labour. |  | Participants will be followed for the duration of labor unit stay, an expected average of one hour | 
| Drop in the hemoglobin and hematocrit levels |  | At the 24th hour,postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum hemorrhage, Third stage of labour, Oxytocin, Uterotonics, Active management of third stage of labour