Effect of Early Versus Traditional Hospital Discharge on Maternal Outcome

NCT ID: NCT03475303

Last Updated: 2018-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-31

Study Completion Date

2018-12-31

Brief Summary

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This study will investigate the effect of early hospital discharge versus traditional one on maternal outcome for women undergoing elective cesarean sections.

aim of the work is to assess rate of maternal hospital revisits after early hospital discharge at 8-12 hours following elective cesarean delivery compared to the current practice of discharge at 24-48 hours postoperatively.

Detailed Description

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The effect of early versus traditional hospital discharge on maternal outcome for women undergoing elective cesarean section

Randomized clinical trial

Protocol of a thesis for partial fulfillment of master degree in obstetrics and gynecology

Postgraduate Student: Hebatallah Saad Sedky Mohamed Degree: M.B.B.Ch., faculty of medicine- Alexandria university (2013)

Co-DIRECTOR: Prof. Dr. Ahmed Hamdy Nagiub Abdulrahman Academic Position: professor of Obstetrics and Gynecology Department: faculty of medicine- Ain Shams University

Co-DIRECTOR: Dr. Mohamed Esmat Abbas Shawky Academic Position: Lecturer of Obstetrics and Gynecology Department: faculty of medicine- Ain Shams University

What is already known on this subject? What does this study add? The rate of cesarean delivery is increasing, in developing countries, its rate ranges from 13 to 47% of all cases of delivery (Gibbons et al 2010). Current practice is to discharge women from hospital 24-48 hours after cesarean delivery, however in some rural areas there is a common practice of earlier discharge. The effect of earlier discharge on women health is controversial. The present study will investigate the possibility of earlier discharge to reduce the cost of hospitalization and postoperative care, increase the turnover rate of obstetric hospitals and improve maternal outcome.

Many studies were concerned by early discharge of patients as there is evidence for colorectal surgery suggests that enhanced recovery programmes can reduce hospital stays by 0.5-3.5 days compared with conventional care (Fiona Paton et al 2014).

The average hospital stay following Cesarean delivery in most hospitals is 2 to 4 days (Tan et al 2012). Hospitalization allows close monitoring of women and early discovery and management of complication. Early discharge would, therefore, be a disadvantage and may delay identification and treatment of maternal and infant morbidity (National Institute of Health 2011). In contrast, several studies concluded that early discharge after Cesarean delivery is not associated with maternal readmissions (Brown et al 2011) and is associated with more maternal satisfaction and lesser cost (Umbeli et al 2010) and will decrease burden on medical facilities, increase turnover of obstetrics, reduce the cost of postoperative care, reduce rate of hospital acquired complications and Improve maternal neonatal relationship.

Conditions

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The Effect of Early Versus Traditional Hospital Discharge for Women Undergoing Elective Cesarean Section

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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early hospital discharge

women will be discharged early from hospital 12 hours postoperatively after elective cesarean sections.

Group Type EXPERIMENTAL

early hospital discharge

Intervention Type BEHAVIORAL

early hospital discharge at 8-12 hours for women undergone elective cesarean section

Interventions

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early hospital discharge

early hospital discharge at 8-12 hours for women undergone elective cesarean section

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age between 20 and 35 years

* Gestational age between 37-42 weeks
* BMI less than 30 kg/m2
* Have normal uncomplicated pregnancy
* Planned lower uterine segment Cesarean section
* Planned for primigravida or previous one or two Cesarean sections
* Planned to have spinal anesthesia
* Cesarean sections without intra-operative complications
* Accepting to participate in the study

Exclusion Criteria

* • Emergency Cesarean section

* Gestational age less than 37 or more than 42 weeks
* BMI 30 kg/m2 or more.
* Multiple pregnancies
* Polyhydraminos
* Abnormal placenta
* Premature rupture of membranes
* Previous abdominal surgeries or uterine surgeries
* Not more than previous two Cesarean sections
* Anemia: Hemoglobin level less than 10 g/dl
* Cesarean section with intraoperative complications
* General anesthesia
* Fibroid uterus
* RH incompatibility ( as there maybe delay of availability of anti-d immunoglobulins)
* History of complicated pregnancy or delivery
* Medical disorders(hypertension, diabetes mellitus, cardiac, pulmonary, renal, hepatic, endocrine and autoimmune disorders).
* Women refusing participating in the study
* Women having any contraindications or refusing spinal anesthesia
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Heba Saad

principle investigator, Ain Shams university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hebatallah S Sedky, M.B.B.Ch

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ainshams maternity hospital

Cairo, EGY 818, Egypt

Site Status RECRUITING

Ainshams maternity hospital

Cairo, Egy818, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hebatallah S Sedky, M.B.B.Ch

Role: CONTACT

01145797676

Mohamed E Abbas, lecturer

Role: CONTACT

01007644642

Facility Contacts

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Hebatallah S Sedky, M.B.B.Ch

Role: primary

01145797676

Mohamed E Abbas, lecturer

Role: backup

01007644642

Hebatallah S Sedky, M.B.B.Ch

Role: primary

01145797676

Mohamed E Abbas, lecturer

Role: backup

01007644642

References

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Adanikin AI, Orji EO, Fasubaa OB, Onwudiegwu U, Ijarotimi OA, Olaniyan O. The effect of post-cesarean rectal misoprostol on intestinal motility. Int J Gynaecol Obstet. 2012 Nov;119(2):159-62. doi: 10.1016/j.ijgo.2012.05.033. Epub 2012 Aug 25.

Reference Type RESULT
PMID: 22925817 (View on PubMed)

Other Identifiers

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Early discharge

Identifier Type: -

Identifier Source: org_study_id

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