Clinical trial NCT05679323: Evaluation of Early Discharge After Cesarean Section
Official title: The Effect of Early Versus Traditional Hospital Discharge on Activities of Daily Livingfor Women Undergoing Elective Cesarean Section.An Observational Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Discharge of Patients After Cesarean Section
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 158
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women admitted to Ain Shams University Maternity Hospital scheduled for elective lower-segment cesarean section

Brief summary: The rate of cesarean delivery is increasing, in developing countries, its rate ranges from 13 to 47% of all cases of delivery. This huge volume of cesarean deliveries has a great financial burden on the healthcare system. Rising hospital costs have led to the implementation of an early discharge policy after surgeries.

Detailed description: Cesarean section (CS) is the most commonly performed surgical procedure worldwide that effectively prevents maternal and newborn mortality when used for medically indicated reasons. Compared with vaginal delivery, however, the procedure is associated with a higher risk of various maternal complications, such as maternal infection and subsequent pregnancy complications, and a higher likelihood of re-hospitalization within six weeks of delivery. Furthermore, the likelihood of maternal morbidity increases for mothers who repeatedly undergo cesarean delivery. CS typically implies a hospital stay for two to three days, whereas parous women are often discharged within a few hours after an uncomplicated vaginal birth. However, the period after CS includes recovery from surgery as well as adapting to motherhood.

According to World Health Organization, the cesarean section rate will increase to 28.5% of total live births by the year 2030. This huge volume of cesarean deliveries and increasing cesarean section rate has an incremental burden on the healthcare system, leading to higher bed occupancy and financial pressure on the patients and health facilities. Postpartum stay at hospitals is steadily declining in the UK and other countries due to cost savings. Rising hospital costs are one of the factors in early discharge.

According to The American College of midwifery and gynecology, earlier discharge is a choice if the baby is ready to go home, though, the mother should have basic requirements such as normal blood pressure, no symptoms of infection, and adequate pain control. Also, the National institute for health and care excellence (NICE) guidelines recommend "women who are recovering well, are apyrexial and do not have complications following Caesarean Section should be offered early discharge (after 24 hours) from the hospital and follow up at home.

Eligibility criteria: Inclusion Criteria:

* BMI ≤ 35 kg/m2
* Gestational age at delivery from 37 0/7 to 42 0/7 weeks of gestation
* Uncomplicated pregnancy
* Cesarean section under spinal anesthesia with no intra-operative complications
* Uneventful postoperative course

Exclusion Criteria:

* Complicated pregnancy (Multiple pregnancies, Polyhydramions, Abnormal placenta, Premature rupture of membranes).
* Medical disorders (diabetes, hypertension, cardiac, renal, endocrinological disorders).

Primary outcomes:
measure: Activities of daily living
timeFrame: The first week after cesarean section
Secondary outcomes:
measure: Wound assessment
timeFrame: First postpartum visit 1 week after the cesarean section
measure: Return to normal bowel activities
timeFrame: First 48 hours after cesarean section
measure: initiation of successful breast feeding
timeFrame: First postpartum visit 1 week after the cesarean section
measure: Neonatal readmission
timeFrame: First postpartum visit 1 week after the cesarean section
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university maternity hospital
Study officials:
affiliation: Ainshams university maternity hospital
name: Ahmed M ElMaraghy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ainshams university maternity hospital
name: Ahmed H Naguib, MD
role: STUDY_DIRECTOR
affiliation: Ainshams university maternity hospital
name: Ahmed M Fahim Hemaid, MD
role: STUDY_CHAIR
References:
citation: Fikrie A, Zeleke R, Bekele H, Seyoum W, Hailu D, Wayessa ZJ, Tufa G, Utura T, Matie M, Oda GD. Time-to-recovery after cesarean section delivery among women who gave birth through cesarean section at Hawassa University Comprehensive Specialized Hospital, South Ethiopia: A prospective cohort study. PLOS Glob Public Health. 2022 Oct 5;2(10):e0000696. doi: 10.1371/journal.pgph.0000696. eCollection 2022.
citation: Sakai-Bizmark R, Ross MG, Estevez D, Bedel LEM, Marr EH, Tsugawa Y. Evaluation of Hospital Cesarean Delivery-Related Profits and Rates in the United States. JAMA Netw Open. 2021 Mar 1;4(3):e212235. doi: 10.1001/jamanetworkopen.2021.2235.
citation: Kruse AR, Lauszus FF, Forman A, Kesmodel US, Rugaard MB, Knudsen RK, Persson EK, Uldbjerg N, Sundtoft IB. Effect of early discharge after planned cesarean section on recovery and parental sense of security. A randomized clinical trial. Acta Obstet Gynecol Scand. 2021 May;100(5):955-963. doi: 10.1111/aogs.14041. Epub 2020 Dec 25.
citation: 4- Gupta S, Gupta A, Baghel AS, Sharma K, Choudhary S, Choudhary V. Enhanced recovery after cesarean protocol versus traditional protocol in elective cesarean section: A prospective observational study. J Obstet Anaesth Crit Care 2022;12:28-33
citation: Ghaffari P, Vanda R, Aramesh S, Jamali L, Bazarganipour F, Ghatee MA. Hospital discharge on the first compared with the second day after a planned cesarean delivery had equivalent maternal postpartum outcomes: a randomized single-blind controlled clinical trial. BMC Pregnancy Childbirth. 2021 Jun 30;21(1):466. doi: 10.1186/s12884-021-03873-8.
citation: 6- Trikha A, Kaur M. Enhanced recovery after surgery in obstetric patients - Are we ready?. J Obstet Anaesth Crit Care 2020;10:1-3