Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss

Post Partum Hemorrhage Clinical Trial

Official title:

Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06351969
• Other study ID #: Ms 9-12-2023
• Status: Recruiting
• Start date: December 21, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Benha University
• Contact: Ahmed Abdelsalam Ahmed, resident
• Phone: +201065832720
• Email: ahmedupwork42[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim of the Work is To determine the significance of the placental thickness and the thickness of the uterine muscle layer at placenta attachment in the prediction of postpartum hemorrhage and to evaluate both of them as as parameters for identifying high-risk patients.

Description:

PPH remains the most common cause of maternal mortality all over the world

PPH is a serious complication ) is a serious complication of labor and delivery with an incidence of approximately 5-10% and a mortality rate 0.5:1%

PPH can also be a cause of long-term severe morbidity and approximately 12% of women who survive PPH will have severe anaemia A significant percentage of deaths due to PPH can be due to a lack in assessing bleeding amount. Clinically assessing bleeding through inspection underestimates the actual bleeding volume and depending on haemodynamic abnormalities may be to late as effective countermeasures are often not taken in time so identifying pregnant women at risk of PPH prior to delivery is crucial to prevent PPH .

The leading cause of PPH is thought to be uterine atony - the failure of the uterus to contract fully after delivery of the placenta. PPH resulting from uterine atony is a major preventable cause of maternal morbidity and mortality, especially in developing countries .(B-Lynch et al., 2006)

Risk factors for PPH and its main causes, including weak uterine contractions, birth canal lacerations, placental factors, and coagulation abnormalities have been relatively well studied .

However the effect of placental attachment on the thickness of the myometrium and its correlation with PPH is not well studied . By exploring the potential correlation between thinner myometrium at the placenta and a higher incidence of PPH we can reduce mortality occuring with PPH. this study highlight the significance of evaluating the impact of placental attachment on myometrial thickness and placenta thickness in the context of PPH

The study will be carried out on 150 pregnant women, who will undergo delivery at benha university hospital either by vaginal delivery or cesarean section either as elective palnned at operative list or admitted to Obstetrics ER after complete clinical evaluation and decision taken by staff member of Benha gynecology and obstetrics department.

Informed consent will be obtained from all participants prior to commencing the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Term pregnancy (37 wk gastation and more )

• Single viable fetus

Exclusion Criteria:

• Severe hematological disorders that could cause abnormal coagulation

• Placental implantation abnormalities or placental abruption

• Uterine anomalies, including congenital or acquired structural abnormalities.

• Previous history of PPH

• category 1 CS and category 2 CS

• Multiple pregnancy

• Preterm labour

• IUFD

Related Conditions & MeSH terms

• Hemorrhage
• Post Partum Hemorrhage
• Postpartum Hemorrhage

Locations

Country	Name	City	State
Egypt	Benha Univeristy	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

B-Lynch, C., Keith, L., Lalonde, A. & Karoshi, M. (2006). A textbook of postpartum haemorrhage: a comprehensive guide to evaluation,managementand surgical intervention, New Delhi, India, Japee Brothers

Liao JB, Buhimschi CS, Norwitz ER. Normal labor: mechanism and duration. Obstet Gynecol Clin North Am. 2005 Jun;32(2):145-64, vii. doi: 10.1016/j.ogc.2005.01.001. — View Citation

Ononge S, Mirembe F, Wandabwa J, Campbell OM. Incidence and risk factors for postpartum hemorrhage in Uganda. Reprod Health. 2016 Apr 14;13:38. doi: 10.1186/s12978-016-0154-8. — View Citation

Weeks A. The prevention and treatment of postpartum haemorrhage: what do we know, and where do we go to next? BJOG. 2015 Jan;122(2):202-10. doi: 10.1111/1471-0528.13098. Epub 2014 Oct 7. — View Citation

Widmer M, Piaggio G, Nguyen TMH, Osoti A, Owa OO, Misra S, Coomarasamy A, Abdel-Aleem H, Mallapur AA, Qureshi Z, Lumbiganon P, Patel AB, Carroli G, Fawole B, Goudar SS, Pujar YV, Neilson J, Hofmeyr GJ, Su LL, Ferreira de Carvalho J, Pandey U, Mugerwa K, Shiragur SS, Byamugisha J, Giordano D, Gulmezoglu AM; WHO CHAMPION Trial Group. Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. N Engl J Med. 2018 Aug 23;379(8):743-752. doi: 10.1056/NEJMoa1805489. Epub 2018 Jun 27. — View Citation

WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26. Erratum In: Lancet. 2017 May 27;389(10084):2104. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating Placental Thickness in cm and Thickness of Uterine Muscle in cm at Placenta Attachment in Prediction of Postpartum Blood Loss	Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss	follow up blood loss in ml intraoperative and 24 hour post operative