Condition category
Pregnancy and Childbirth
Date applied
31/05/2005
Date assigned
08/09/2005
Last edited
14/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Roderick Larsen-Reindorf

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
Komfo Anokye Teaching Hospital
Kumasi
-
Ghana
+233 244 271 689
larsdorf@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Short stay in hospital after uncomplicated caesarean section results in lower wound infection rates and higher patient satisfaction

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Caesarean section

Intervention

Short stay (3-4 days) in hospital following uncomplicated caesarean section, compared with traditional 7 day stay

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Wound infection rates

Secondary outcome measures

1. Patient satisfaction
2. Hospital Readmission rate
3. Endometritis

Overall trial start date

01/08/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Women attending Komfo Anokye Teaching Hospital for delivery by caesarean section
a. The patient must stay within 16 km (10 miles) radius from the hospital on discharge
b. Written or thumb-printed informed consent to participate in the study
c. Uncomplicated caesarean section
d. Must not have medical or obstetric complications in the exclusion
criteria

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

856

Participant exclusion criteria

a. Patients with sickle cell disease (SCD), hypertensive disorders of pregnancy, diabetic mellitus
b. Patients with sepsis
c. Patients with conditions warranting longer stay in the hospital such as
ruptured uterus, genital tract sepsis, persistent fever, need for blood transfusion and continuous bladder drainage
d. Referred patients with prolonged labor, ruptured uterus,
chorioamnionitis
e. Patients who do not feel they have sufficient support at home

Recruitment start date

01/08/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Ghana

Trial participating centre

Department of Obstetrics and Gynaecology
Kumasi
-
Ghana

Sponsor information

Organisation

Komfo Anokye Teaching Hospital (Ghana)

Sponsor details

Department of Obstetrics and Gynaecology
Komfo Anokye Teaching Hospital
Kumasi
-
Ghana
+233 244 271 689
larsdorf@yahoo.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Effective Health Care Alliance Programme, Liverpool School of Tropical Medicine (United Kingdom)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Komfo Anokye Teaching Hospital, Kumasi (Ghana)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes