Randomised controlled trial comparing shorter versus longer hospital stay after uncomplicated caesarean section
| ISRCTN | ISRCTN35456604 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35456604 |
| Protocol serial number | N/A |
| Sponsor | Komfo Anokye Teaching Hospital (Ghana) |
| Funders | Effective Health Care Alliance Programme, Liverpool School of Tropical Medicine (United Kingdom), Komfo Anokye Teaching Hospital, Kumasi (Ghana) |
- Submission date
- 31/05/2005
- Registration date
- 08/09/2005
- Last edited
- 14/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Roderick Larsen-Reindorf
Scientific
Scientific
Department of Obstetrics and Gynaecology
Komfo Anokye Teaching Hospital
Kumasi
-
Ghana
| Phone | +233 244 271 689 |
|---|---|
| larsdorf@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Single-centre |
| Scientific title | |
| Study objectives | Short stay in hospital after uncomplicated caesarean section results in lower wound infection rates and higher patient satisfaction |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Caesarean section |
| Intervention | Short stay (3-4 days) in hospital following uncomplicated caesarean section, compared with traditional 7 day stay |
| Intervention type | Other |
| Primary outcome measure(s) |
Wound infection rates |
| Key secondary outcome measure(s) |
1. Patient satisfaction |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 856 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Ghana
Study participating centre
Department of Obstetrics and Gynaecology
Kumasi
-
Ghana
-
Ghana
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
