Clinical trial NCT03006380: Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery
Official title: Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postpartum Hemorrhage
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.
12. Chorioamnionitis.
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

Primary outcomes:
measure: blood loss in vaginal delivery
timeFrame: blood loss in the third stage of labor (Up to 60 min after delivery of the baby)
Secondary outcomes:
measure: primary postpartum hemorrhage
timeFrame: within 24 hours after delivery
measure: changes in hemoglobin and hematocrit
timeFrame: before delivery and after 6 hours
measure: retained placenta
timeFrame: more than 30 minutes after delivery
measure: length of 3rd stage of labor
timeFrame: Up to 60 min from delivery of baby till delivery of placenta
measure: manual removal of the placenta
timeFrame: if not separated after 30 minutes from delivery
measure: blood pressure
timeFrame: to be measured before delivery after 15 minutes,1 hour,6 hours
measure: maternal pain
timeFrame: during third stage of labor
measure: maternal nausea and vomiting
timeFrame: during 3rd stage of labor
measure: secondary postpartum hemorrhage
timeFrame: after 24 hours and before 6 weeks from delivery
measure: surgical intervention to stop the bleeding
timeFrame: within 24 hours after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: Amr Yehia, MD, MRCOG
role: STUDY_DIRECTOR
References: