Single Dose Ceftriaxone and Metronidazole Versus Multiple Doses for Antibiotic Prophylaxis at Elective Cesarean Section.

Post Operative Infections Clinical Trial

— SDvMD  

Official title:

Single Dose Ceftriaxone and Metronidazole Versus Multiple Doses for Antibiotic Prophylaxis at Elective Cesarean Section in Mulago Hospital. A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736682
• Other study ID #: 2013/HD07/658U
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2016
• Last updated: April 12, 2016
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Drug AuthorityUganda: National Council for Science and Technoogy
• Study type: Interventional

Clinical Trial Summary

Delivery by Cesarean section is increasing worldwide and this is the most important risk factor for post partum infection where there is a 5-20% risk of developing post partum infection than women who deliver vaginally Provision of single dose broad spectrum intravenous antibiotics 30-60 minutes before cesarean section has been found to be as effective as multiple doses in reducing post operative infections. At Mulago National referral Hospital mothers who have had elective and are at low risk of post partum infection also receive multiple doses of intravenous antibiotics for up to 7 days. The rationale of the study is to further inform us that single dose preoperative antibiotic prophylaxis is effective in prevention of post operative infection in mothers delivered by elective cesarean section.

Description:

This is going to be an open label randomized controlled clinical trial that will involve 174 mothers delivered by elective cesarean section in Mulago National Referral hospital ward 5B antenatal and post natal wards.

Mulago hospital is at the apex of a 6 tier health system and is the largest public hospital with 31,400 deliveries annually 26.14% by cesarean section and of these 5.6% are elective cesarean sections.

Simple randomization was done where 174 cards were numbered 1-174 {(87 labelled Single Dose (SD) and 87 labelled Multiple Dose (MD)} inserted in an envelop shuffled and then the mother was allowed to pick a card randomly. This was done by the research assistant who reviewed the mother again in theater to ascertain if they still met the eligibility before the intervention was done.

Method This will be an open label single center superiority randomized clinical trial involving 174 eligible participants (87 in each arm) who will have delivered by elective cesarean section in Mulago hospital. They will be randomly allocated into two arms. One arm will receive single dose IV ceftriaxone 2g and metronidazole 500mg 30-60 minutes before the operation and the second arm will receive IV ceftraixone 1g with 500 mg of metronidazole during the operation and continue for 72 hours and discharged with oral antibiotics.

The mothers will be reviewed twice daily for evidence of infection. Their vitals (BP, Pulse, Temperature and respiratory rate), state of the wound and uterus, amount color and smell of the lochia during the first 2-3 post operative days. Both arms will have a 14 day follow up where they will come back for review on the 7th and 14th post operative day.

Objective:

The general objective is to compare the incidence of post operative infections among mothers that receive single dose pre operative Ceftriaxone and metronidazole compared to multiple doses at delivery by elective cesarean section in Mulago National Referral Hospital. at 14 day post operative.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Antenatal mothers who have an indication for elective cesarean section in New Mulago hospital.

Exclusion Criteria:

• Mothers who have a history of allergy to any of the drugs in the study, Mother with visible infection at any site or elevated body temperature before going to theatre, Those with rapture of membranes, Mothers who went into labor, Mother who has had use of antibiotics in the last 7 days, WHO Clinical HIV stage III and IV and mothers who do not consent to the study.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Operative Infections

Intervention

Drug:
• Single dose antibiotic
Single dose arm receive 2g of IV Ceftriaxone and 500 mgs ofIntra venous Metronidazole given to the mothers 30-60 minutes pre operative.
• Multiple dose antibiotic
Multiple dose arm receive 1 g of IV Cetriaxone plus 500 mgs during surgery and there after IV ceftriaxone once a day for 3 days and IV Metronidazole 500mgs during surgery and there after every 8 hours for 3 days.

Locations

Country	Name	City	State
Uganda	Mulago National Refferal Hospital	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative wound infections	Compare for incidence of post operative wound infection among mothers that receive single dose versus multiple dose antibiotics	14 days	No
Secondary	clinical endometritis	Compare the incidence of clinical endometritis among mothers that receive single versus multiple dose antibiotics	14 days	No
Secondary	febrile morbidity	compare the incidence of post operative febrile morbidity among mothers that receive single versus multiple doses	14 days	No