Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery

Postpartum Hemorrhage Clinical Trial

Official title:

Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03006380
• Other study ID #: oxytocin
• Status: Recruiting
• Phase: Phase 2
• First received: December 22, 2016
• Last updated: March 13, 2017
• Start date: August 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2017
• Source: Ain Shams Maternity Hospital
• Contact: Reham Marie, MRCOG
• Phone: +201212977339
• Email: rehamfarghal84[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• oxytocin
Ecbolic used to reduce blood loss

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss in vaginal delivery		blood loss in the third stage of labor (Up to 60 min after delivery of the baby)
Secondary	primary postpartum hemorrhage		within 24 hours after delivery
Secondary	changes in hemoglobin and hematocrit		before delivery and after 6 hours
Secondary	retained placenta		more than 30 minutes after delivery
Secondary	length of 3rd stage of labor		Up to 60 min from delivery of baby till delivery of placenta
Secondary	manual removal of the placenta		if not separated after 30 minutes from delivery
Secondary	blood pressure		to be measured before delivery after 15 minutes,1 hour,6 hours
Secondary	maternal pain		during third stage of labor
Secondary	maternal nausea and vomiting		during 3rd stage of labor
Secondary	secondary postpartum hemorrhage		after 24 hours and before 6 weeks from delivery
Secondary	surgical intervention to stop the bleeding		within 24 hours after delivery