The Effect of Early Versus Traditional Hospital Discharge for Women Undergoing Elective Cesarean SectionNCT03475303
Effect of Early Versus Traditional Hospital Discharge on Maternal Outcome
A study testing early hospital discharge in people with The Effect of Early Versus Traditional Hospital Discharge for Women Undergoing Elective Cesarean Section, run by Ain Shams University at 2 sites in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- The Effect of Early Versus Traditional Hospital Discharge for Women Undergoing Elective Cesarean Section
- What is being tested?
- early hospital discharge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesEgypt
- Study dates
- Mar 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- Planned to have spinal anesthesia
- Cesarean sections without intra-operative complications
- Accepting to participate in the study
Who cannot join
- • Emergency Cesarean section
- Gestational age less than 37 or more than 42 weeks
- BMI 30 kg/m2 or more.
- Multiple pregnancies
- Polyhydraminos
- Abnormal placenta
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- 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
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Ainshams maternity hospital
Cairo, EGY 818, 11311
Hebatallah S Sedky, M.B.B.Ch, 01145797676, heba.allah_saad@yahoo.com
Mohamed E Abbas, lecturer, 01007644642, moh_3smat@yahoo.com
- Recruiting
Ainshams maternity hospital
Cairo, Egy818, 11311
Hebatallah S Sedky, M.B.B.Ch, 01145797676, heba.allah_saad@yahoo.com
Mohamed E Abbas, lecturer, 01007644642, moh_3smat@yahoo.com
About this study
Official title: The Effect of Early Versus Traditional Hospital Discharge on Maternal Outcome for Women Undergoing Elective Cesarean Section
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.
Read the detailed description
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.
- Being tested
- early hospital discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early hospital dischargeBehavioural
early hospital discharge at 8-12 hours for women undergone elective cesarean section
| Study group | Role | What they receive |
|---|---|---|
| early hospital discharge | Experimental | women will be discharged early from hospital 12 hours postoperatively after elective cesarean sections. Receives: Behavioral: early hospital discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of maternal hospital revisits
the aim is to reduce rate of maternal hospital revisits after discharge from the hospital which will be assessed by questionnaire
Measured: one week postoperatively
Secondary outcomes (1)
Maternal and family satisfaction,
the aim is to get the maximum satisfaction which will be assessed by questionnaire
Measured: one week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study startMar 2018 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Effect of Early Versus Traditional Hospital Discharge for Women Undergoing Elective Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Saad, Ain Shams University
- Investigators
- Hebatallah S Sedky, M.B.B.Ch, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475303
- Sponsor's protocol ID
- Early discharge
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22925817
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Versus Traditional Hospital Discharge on Maternal Outcome for Women Undergoing Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT03475303
- Acronym / sponsor ID
- Early discharge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early hospital discharge | Experimental | Behavioral: early hospital dischargewomen will be discharged early from hospital 12 hours postoperatively after elective cesarean sections. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age between 20 and 35 years
Key exclusion criteria (18 listed)
- • Emergency Cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early hospital dischargeearly hospital discharge at 8-12 hours for women undergone elective cesarean section | Behavioural | early hospital discharge |
Primary outcome
Rate of maternal hospital revisits
Time frame: one week postoperatively
the aim is to reduce rate of maternal hospital revisits after discharge from the hospital which will be assessed by questionnaire
1 secondary outcome
Maternal and family satisfaction,
Time frame: one week postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Results publication: PubMed 22925817Adanikin 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hebatallah S Sedky, M.B.B.Ch principal investigator
Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early hospital discharge in people with The Effect of Early Versus Traditional Hospital Discharge for Women Undergoing Elective Cesarean Section, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hebatallah S Sedky, M.B.B.Ch (01145797676, heba.allah_saad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of maternal hospital revisits (time frame: one week postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03475303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.