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

NCT ID: NCT02736682

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-03-31

Brief 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.

Detailed 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.

Conditions

Post Operative Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single dose antibiotic

2g of intra venous Ceftriaxone and 500 mgs Intra venous metronidazole is administered to the mothers as a Single dose pre-operative30-60 minutes before surgery.

Group Type: EXPERIMENTAL

Single dose antibiotic

Intervention Type: DRUG

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 doses of IV Ceftriaxone 1g and metronidazole 500mgs given to the mother during surgery there after Ceftriaxone 1g every day for 3 days and IV metronidazole 500 mgs every 8 hours for 3 days.

Group Type: ACTIVE_COMPARATOR

Multiple dose antibiotic

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Epicefin, E.I.P.I.CO.Unique Metrogyl injection.; Epicefin, E.I.P.I.CO, Unique Metrogyl injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Makerere University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mugisa Alex Gideon, MBChB.

Role: PRINCIPAL_INVESTIGATOR

Makerere University Collage of Health Sciences, Department of Obstetrics and Gynecology

Paul Kiondo, MD, MMeD,PhD

Role: STUDY_DIRECTOR

Makerere University Collage of Health Sciences, Department of Obstetrics and Gynecology

Imelda Namagembe, MD, MMeD, MPH

Role: STUDY_DIRECTOR

Mulago NAtional Referral Hospital

Locations

Mulago National Refferal Hospital

Kampala, , Uganda

Countries

Uganda

References

Williams MJ, Carvalho Ribeiro do Valle C, Gyte GM. Different classes of antibiotics given to women routinely for preventing infection at caesarean section. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD008726. doi: 10.1002/14651858.CD008726.pub3.

Reference Type: DERIVED

PMID: 33661539 (View on PubMed)

Other Identifiers

2013/HD07/658U

Identifier Type: -

Identifier Source: org_study_id