ObstetricsNCT00370708
Early Oral Intake Following Cesarean Surgery
A study testing Oral Intake following admittance to the postpartum ward in people with Obstetrics and Surgery, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
In this study we are trying to compare the safety and financial benefit of starting the realimentation early versus conventional oral intake following the Cesarean surgery in Iran. 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
- Obstetrics, Surgery
- What is being tested?
- Oral Intake following admittance to the postpartum ward
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Apr 2003to Feb 2004
- 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
- Women who had elective cesarean deliveries under regional anesthesia
Who cannot join
- Receiving general anesthesia, magnesium sulfate or insulin.
- Coming across an intraoperative bowel injury.
- Having any medical or gastrointestinal problem that prohibits early feeding
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Obstetrics and Gynecology, Arash Hospital
Tehran, Tehran Province, 19986
About this study
Official title: Early Oral Intake Following Elective Cesarean Surgery in Iranian Women; the Economic Burdens and Patient Satisfaction
In this study we are trying to compare the safety and financial benefit of starting the realimentation early versus conventional oral intake following the Cesarean surgery in Iran.
Read the detailed description
Cesarean delivery is announced to constitute 50% of deliveries in the Capital and 39% of all the deliveries nationwide, which is far beyond the acceptable international normal range, according to the official site of the Ministry of Health and Medical Education of the Islamic Republic of Iran [http://www.mohme.gov.ir/HNDC/Indicators/Simaye_Salamt/Simaye_Salamat.htm]. This high rate of elective cesarean deliveries might be due to several reasons which are far beyond the scope of this study. Here we tried to see whether the reduction in the time of hospitalization for these patients is safe at the expense of earlier oral realimentation and to see whether this strategy increases the patients' satisfaction or not.
- Conditions
- Obstetrics, Surgery
- Being tested
- Oral Intake following admittance to the postpartum ward
- Keywords
- Cesarean, Oral, Intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Intake following admittance to the postpartum wardProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of Oral Intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startApr 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObstetricsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Afsaneh Tehranian, Assist Pro, Principal investigator, Department of Obstetrics and Gynecology, Arash Hospital, Tehran University of Medical Sciences, Tehran/Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370708
- Sponsor's protocol ID
- 1383FK
- Status last verified
- Apr 2004
- First submitted
- 31 Aug 2006
- Last updated
- 7 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Oral Intake Following Elective Cesarean Surgery in Iranian Women; the Economic Burdens and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT00370708
- Acronym / sponsor ID
- 1383FK
- Conditions
- Obstetrics, Surgery
- Keywords
- Cesarean, Oral, Intake
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Feb 2004
- First posted
- 1 Sep 2006 (estimated)
- 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.
In this study we are trying to compare the safety and financial benefit of starting the realimentation early versus conventional oral intake following the Cesarean surgery in Iran.
Detailed description
Cesarean delivery is announced to constitute 50% of deliveries in the Capital and 39% of all the deliveries nationwide, which is far beyond the acceptable international normal range, according to the official site of the Ministry of Health and Medical Education of the Islamic Republic of Iran [http://www.mohme.gov.ir/HNDC/Indicators/Simaye_Salamt/Simaye_Salamat.htm]. This high rate of elective cesarean deliveries might be due to several reasons which are far beyond the scope of this study. Here we tried to see whether the reduction in the time of hospitalization for these patients is safe at the expense of earlier oral realimentation and to see whether this strategy increases the patients' satisfaction or not.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who had elective cesarean deliveries under regional anesthesia
Key exclusion criteria (3 listed)
- Receiving general anesthesia, magnesium sulfate or insulin.
- Coming across an intraoperative bowel injury.
- Having any medical or gastrointestinal problem that prohibits early feeding
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 |
|---|---|---|
| Oral Intake following admittance to the postpartum ward | Procedure or surgery | – |
Primary outcome
Tolerance of Oral Intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2006.
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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.
Afsaneh Tehranian, Assist Pro principal investigator
Department of Obstetrics and Gynecology, Arash Hospital, Tehran University of Medical Sciences, Tehran/Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Intake following admittance to the postpartum ward in people with Obstetrics and Surgery, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 7 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of Oral Intake. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2006.