Randomized controlled study to assess the efficacy and safety of the timing of administration of prophylactic oxytocin via intramuscular route (before compared to after placental delivery) on blood loss in vaginal delivery.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Double (Participant, Outcomes Assessor)
- Study Primary Completion Date: August 2017
400 patients will be recruited for the study,Informed consent will be obtained from all patients following the research criteria once they are admitted in active labor, but they will be enrolled and randomized only when they reach the second stage of labor (fully dilated cervix) as it will be difficult in this stage to counsel patients.
The recruited patients will be subjected to the following:
- History taking: with particular emphasis on past medical history (especially for bleeding tendency), past obstetric history.
- Checking vital signs, General and abdominal examination.
- laboratory investigations: complete blood count (CBC)
- Findings of the initial obstetric evaluation follow up, labor duration and the need for oxytocin augmentation will be recorded through a partogram.
- All deliveries will be attended by a senior resident in the hospital.
- Included patients will receive the medication according to randomization tables.
- After allocation, patients will be excluded only if they required cesarean section, instrumental delivery or had multiple or deep vaginal tears that compromise estimation of uterine blood loss.
- All patients will undergo gentle traction to the umbilical cord while providing counter traction against the uterine fundus after signs of placental separation; appearance of bleeding, elongation of the cord.
- All patients will undergo cord clamping and cutting within 30 seconds of delivery.
- All patients will undergo uterine massage for 30 seconds after placental delivery.
- Vital signs (blood pressure and pulse) will be checked 15 minutes, 1 hour and 6 hours after placental delivery.
- CBC will be collected 6 hours after delivery.
- Drug: oxytocin
- Ecbolic used to reduce blood loss
Arms, Groups and Cohorts
- Experimental: oxytocin before placental delivery
- patients who will receive 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly at delivery of anterior shoulder of the fetus and an identical placebo injection (normal saline, NACL 0.9%) intramuscularly following delivery of the placenta.
- Experimental: oxytocin after placental delivery
- patients who will receive placebo injection (normal saline, NACL 0.9%) intramuscularly at delivery of anterior shoulder of the fetus and 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly following delivery of the placenta.(opposite medication sequence)
Clinical Trial Outcome Measures
- blood loss in vaginal delivery
- Time Frame: blood loss in the third stage of labor (Up to 60 min after delivery of the baby)
- primary postpartum hemorrhage
- Time Frame: within 24 hours after delivery
- changes in hemoglobin and hematocrit
- Time Frame: before delivery and after 6 hours
- retained placenta
- Time Frame: more than 30 minutes after delivery
- length of 3rd stage of labor
- Time Frame: Up to 60 min from delivery of baby till delivery of placenta
- manual removal of the placenta
- Time Frame: if not separated after 30 minutes from delivery
- blood pressure
- Time Frame: to be measured before delivery after 15 minutes,1 hour,6 hours
- maternal pain
- Time Frame: during third stage of labor
- maternal nausea and vomiting
- Time Frame: during 3rd stage of labor
- secondary postpartum hemorrhage
- Time Frame: after 24 hours and before 6 weeks from delivery
- surgical intervention to stop the bleeding
- Time Frame: within 24 hours after delivery
Participating in This Clinical Trial
1. Multiparous women (had previous one, up to four deliveries)
2. Term pregnancy (37 completed weeks at least).
3. Singleton viable cephalic pregnancy.
4. Vaginal delivery.
1. Primigravida.(first pregnancy)
2. Grand multiparous. (had previous 5 or more deliveries)
3. Maternal illness (involving pregnancy induced condition; PIH,GDM or chronic medical condition; hypertension, cardiac , renal problems)
4. Previous cesarean section, uterine surgery.
5. Patients with bleeding tendency.
6. Previous history of Ante-partum hemorrhage.
7. Previous history of postpartum hemorrhage.
8. Abnormal site of the placenta (detected by ultrasound)
9. Macrosomic baby (EFW more than 4000 gm estimated clinically or by ultrasound)
10. polyhydramnios.(detected by ultrasound)
11. Multiple gestation.
13. Suspected fetal problem(anomaly, distress)
14. Instrumental delivery.
15. Multiple or deep vaginal tears that compromise the estimation of uterine blood loss.
16. Cesarean delivery
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 35 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Ain Shams Maternity Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: AMR HELMY YEHIA, Associate Professor of obstetrics and gynecology – Ain Shams Maternity Hospital
- Overall Official(s)
- Amr Yehia, MD, MRCOG, Study Director, Ain Shams University
- Overall Contact(s)
- Reham Marie, MRCOG, +201212977339, firstname.lastname@example.org
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