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OpenTrials
Completed

NCT Number: NCT05679323

Evaluation of Early Discharge After Cesarean Section

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

AinShams university maternity hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

KATZ index of independence in activities of daily living

Other

KATZ index measures self-care tasks using a dichotomous rating (dependent-0/independent-1) including; bathing, dressing, toileting, transferring to and from a chair, maintaining continence, and feeding. Six points are considered independent and 0 points are considered fully dependent. Assessment of each patient is made through a phone call at day 1, 3 and 5 after discharge

Primary outcomes

  1. Activities of daily living

    Time frame: The first week after cesarean section

    Objective assessment is made by the KATZ index of independence of activities of daily living. The Katz index measures six self-care tasks including; bathing, dressing, toileting, transferring, maintaining continence, and feeding using a dichotomous rating (dependent-0/independent-1). Six points are considered independent and 0 points are considered fully dependent

Secondary outcomes

  1. Wound assessment

    Time frame: First postpartum visit 1 week after the cesarean section

    Assessment of the wound by the Southampton wound scoring system will take place 1 week after the cesarean section. It categorizes wound complications on a grade from 0 to V, with the latter being deep or severe wound infection.

  2. Return to normal bowel activities

    Time frame: First 48 hours after cesarean section

    Passage of flatus and stool after the cesarean section

  3. initiation of successful breast feeding

    Time frame: First postpartum visit 1 week after the cesarean section

    Start of lactation

  4. Neonatal readmission

    Time frame: First postpartum visit 1 week after the cesarean section

    The rate of neonatal admission and the reason will be assessed

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

The Effect of Early Versus Traditional Hospital Discharge on Activities of Daily Livingfor Women Undergoing Elective Cesarean Section.An Observational Cohort Study.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2023
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.