Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage

High Risk Pregnancy Clinical Trial

Official title:

Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage in High-risk Patients in Sohag University Hospital: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05479357
• Other study ID #: Soh-Med-22-07-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 28, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: Sohag University
• Contact: Eman M Sabry, MBBCh
• Phone: +201012733125
• Email: emanmahmoud[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison between Carbetocin and Oxytocin as prophylaxis against Primary Postpartum Hemorrhage.

Description:

Patients will be allocated randomly by simple randomization into either 1- the control group which will be given 10 IU oxytocin intravenously, OR 2- the treatment group which will be given 100 micrograms of carbetocin intravenously.

The trial will be conducted on patients with high risk of developing atonic primary postpartum hemorrhage. The trial will be single blinded. All patients fulfilling the inclusion criteria undergoing elective Caesarean section will be approached by the treating physician and will be asked to participate in the study. An informed written consent will be taken from each patient. The data collected will include base line characteristics such as age, parity, body mass index, the risk for Postpartum hemorrhage in each patient, amount of blood loss, blood units given, complete blood picture (pre and post operative) and coagulation profile.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• • High risk patients for post-partum hemorrhage who will subjected to Caeserean section either elective or in labour at or after 36 weeks of gestation. This should include one or more of the following:

1. History of postpartum hemorrhage.

2. Delivery of a macrosomic baby (> 4000 g).

3. Multiple gestation.

4. Polyhydramnios.

5. Grand Multiparity.

6. Interstitial or submucous fibroid. (Single larger than 4 cm or Multiple myomata)

7. Chorioamnionitis.

Exclusion Criteria:

• • Patients without high risk for post-partum hemorrhage.

• Patients at high risk for postpartum hemorrhage but will deliver vaginally.

• Patients with medical disorders complicating pregnancy.

• Patients with coagulation defects.

• Preterm pregnancies.

Related Conditions & MeSH terms

• Hemorrhage
• High Risk Pregnancy
• Postpartum Hemorrhage

Intervention

Drug:
• Oxytocin
10 iu will be given intravenously.
• Carbetocin
100 micrograms will be given intravenously.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & Publications (12)

Brace V, Penney G, Hall M. Quantifying severe maternal morbidity: a Scottish population study. BJOG. 2004 May;111(5):481-4. — View Citation

Chong YS, Su LL, Arulkumaran S. Current strategies for the prevention of postpartum haemorrhage in the third stage of labour. Curr Opin Obstet Gynecol. 2004 Apr;16(2):143-50. Review. — View Citation

Dahlke JD, Mendez-Figueroa H, Maggio L, Hauspurg AK, Sperling JD, Chauhan SP, Rouse DJ. Prevention and management of postpartum hemorrhage: a comparison of 4 national guidelines. Am J Obstet Gynecol. 2015 Jul;213(1):76.e1-76.e10. doi: 10.1016/j.ajog.2015.02.023. Epub 2015 Feb 28. — View Citation

Girault A, Deneux-Tharaux C, Sentilhes L, Maillard F, Goffinet F. Undiagnosed abnormal postpartum blood loss: Incidence and risk factors. PLoS One. 2018 Jan 10;13(1):e0190845. doi: 10.1371/journal.pone.0190845. eCollection 2018. — View Citation

Lawrie TA, Rogozinska E, Sobiesuo P, Vogel JP, Ternent L, Oladapo OT. A systematic review of the cost-effectiveness of uterotonic agents for the prevention of postpartum hemorrhage. Int J Gynaecol Obstet. 2019 Jul;146(1):56-64. doi: 10.1002/ijgo.12836. Epub 2019 May 20. — View Citation

Maher MA, Sayyed TM, Elkhouly NI. Different routes and forms of uterotonics for treatment of retained placenta: a randomized clinical trial. J Matern Fetal Neonatal Med. 2017 Sep;30(18):2179-2184. doi: 10.1080/14767058.2016.1242124. Epub 2016 Oct 19. — View Citation

Mantel GD, Buchmann E, Rees H, Pattinson RC. Severe acute maternal morbidity: a pilot study of a definition for a near-miss. Br J Obstet Gynaecol. 1998 Sep;105(9):985-90. — View Citation

Nyfløt LT, Sandven I, Stray-Pedersen B, Pettersen S, Al-Zirqi I, Rosenberg M, Jacobsen AF, Vangen S. Risk factors for severe postpartum hemorrhage: a case-control study. BMC Pregnancy Childbirth. 2017 Jan 10;17(1):17. doi: 10.1186/s12884-016-1217-0. — View Citation

Nyfløt LT, Stray-Pedersen B, Forsén L, Vangen S. Duration of labor and the risk of severe postpartum hemorrhage: A case-control study. PLoS One. 2017 Apr 6;12(4):e0175306. doi: 10.1371/journal.pone.0175306. eCollection 2017. — View Citation

Waterstone M, Bewley S, Wolfe C. Incidence and predictors of severe obstetric morbidity: case-control study. BMJ. 2001 May 5;322(7294):1089-93; discussion 1093-4. — View Citation

Withanathantrige M, Goonewardene M, Dandeniya R, Gunatilake P, Gamage S. Comparison of four methods of blood loss estimation after cesarean delivery. Int J Gynaecol Obstet. 2016 Oct;135(1):51-5. doi: 10.1016/j.ijgo.2016.03.036. Epub 2016 Jul 4. — View Citation

Zhang WH, Alexander S, Bouvier-Colle MH, Macfarlane A; MOMS-B Group. Incidence of severe pre-eclampsia, postpartum haemorrhage and sepsis as a surrogate marker for severe maternal morbidity in a European population-based study: the MOMS-B survey. BJOG. 2005 Jan;112(1):89-96. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Postpartum Hemorrhage	Amount of Blood Loss in milliliters. Pre-operative patient's Hemoglobin (Hb) level and 24 hours post-operative will be assessed to quantify amount of blood loss. Additionally, all towels prepared for CS will weighed, and the weight will be marked on each pack before autoclaving. All towels (used and unused) will be weighed again after use, and a difference of 1 gm will be considered as equivalent to 1 mL of absorbed blood.	First 24 hours after Delivery