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

NCT05479357 | Unknown DMC

• 1 other identifier: Soh-Med-22-07-02
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atonic Postpartum Hemorrhage; High Risk Pregnancy

Keywords

Atonic Postpartum Hemorrhage; Carbetocin; Oxytocin; High Risk Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

the control group will be given 10 iu intravenously.

Drug: Oxytocin

Carbetocin

ACTIVE COMPARATOR

the treatment group will be given 100 microgram intravenously.

Drug: Carbetocin

Interventions

Oxytocin DRUG

10 iu will be given intravenously.

Oxytocin

Carbetocin DRUG

100 micrograms will be given intravenously.

Carbetocin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• History of postpartum hemorrhage.
• Delivery of a macrosomic baby (\> 4000 g).
• Multiple gestation.
• Polyhydramnios.
• Grand Multiparity.
• Interstitial or submucous fibroid. (Single larger than 4 cm or Multiple myomata)
• Chorioamnionitis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (12)

• 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. doi: 10.1136/bmj.322.7294.1089.

  PMID: 11337436 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.2004.00303.x.

  PMID: 15663404 BACKGROUND

• 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.

  PMID: 25731692 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.1998.tb10262.x.

  PMID: 9763050 BACKGROUND

• Brace V, Penney G, Hall M. Quantifying severe maternal morbidity: a Scottish population study. BJOG. 2004 May;111(5):481-4. doi: 10.1111/j.1471-0528.2004.00101.x.

  PMID: 15104614 BACKGROUND

• Nyflot 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.

  PMID: 28068990 BACKGROUND

• 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.

  PMID: 29320553 BACKGROUND

• Nyflot LT, Stray-Pedersen B, Forsen 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.

  PMID: 28384337 BACKGROUND

• 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.

  PMID: 27677547 BACKGROUND

• 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.

  PMID: 31049950 BACKGROUND

• 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.

  PMID: 27451396 BACKGROUND

• 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. doi: 10.1097/00001703-200404000-00008.

  PMID: 15017343 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; carbetocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Magdy M Ameen, MD

  Faculty of Medicine, Sohag University

  PRINCIPAL INVESTIGATOR

• Ahmed T Ahmed, MD

  Faculty of Medicine, Sohag University

  PRINCIPAL INVESTIGATOR

• Amr O Abdelkareem, MD

  Faculty of Medicine, Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman M Sabry, MBBCh

CONTACT

+201012733125; emanmahmoud@med.sohag.edu.eg

Amr O Abdelkareem, MD

CONTACT

+201001259562; AMR.OTH@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient will be blinded to the drug to be used
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Randomized Clinical Trial (Simple randomization)

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: July 28, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share