Enhanced Recovery After Surgery for Emergency Caesarean Deliveries

Pregnancy Related Clinical Trial

— ERAS-Mbarara  

Official title:

Enhanced Recovery After Surgery Versus Standard Recovery for Emergency Caesarean Deliveries at Mbarara Hospital, Uganda: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518463
• Other study ID #: MUST 0606/2018
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: November 27, 2017

Study information

• Verified date: March 2018
• Source: Mbarara University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Caesarean section (CS) constitutes a large proportion of the total surgical volume in low-income countries. This rate comes with challenges including surgical complications, shortage of beds, and consequently long waiting time for operations and high costs. These have led to the adoption of ERAS in developed countries in a bid to save costs by reducing hospital length of stay without compromising the health of the mother and her baby.

Description:

CS is the most common major surgery at Mbarara Hospital (56.2%). This rate comes with challenges including surgical complications, shortage of beds, and consequently long waiting time for operations. Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages. ERAS has been seen to reduce duration of hospital stay, complications and costs. Although many of the elements of enhanced recovery after surgery are similar, it has not been tested in emergency CS and there is limited data about its applicability in low income settings like Uganda where 95% of CS are emergencies. The aim of this study was to assess the impact of ERAS protocols following emergency caesarean delivery in a low resource setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 27, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• We included women who were ASA 1 and 2 mothers who were delivering by emergency caesarean section using spinal anesthetic technique.

Exclusion Criteria:

• Exclusion criteria included refusal to consent, pregnancy complicated by preeclampsia, antepartum hemorrhage, malaria, gestational diabetes mellitus, physical disability that would prevent postoperative mobilization and mental illness precluding comprehension of protocols.

Related Conditions & MeSH terms

• Emergencies
• Pregnancy Related

Intervention

Combination Product:
• Enhanced recovery after surgery (ERAS)
The ERAS arm was exposed to standard preoperative, intraoperative and postoperative ERAS protocols of care. However, some were modified to our local resources and requirements as well as to the emergency nature of the surgeries.

Locations

Country	Name	City	State
Uganda	Mbarara university of Science and Technology	Mbarara

Sponsors (1)

Lead Sponsor	Collaborator
Mbarara University of Science and Technology

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	Length of hospital stay was measured in hours	Measured from surgery up to 120 hours.
Secondary	Complication rates	These included pain, PONV, headache, pruritus, urine retention, wound infection, puerperal sepsis and readmission	Pain was assessed after 6 hours postoperative; PONV, pruritus and urine retention were assessed for 24 hours; headache was assessed for 1 week; wound infection, puerperal sepsis and readmission were assessed up to 30 days postoperative