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

12 april 2016 uppdaterad av: Makerere University

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

174

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Uganda
      • Kampala, Uganda, 00256
        • Mulago National Refferal Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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.
Andra namn:
  • Epicefin, E.I.P.I.CO.Unique Metrogyl injection.
Aktiv komparator: 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.
Läkemedel: 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.
Andra namn:
  • Epicefin, E.I.P.I.CO, Unique Metrogyl injection

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Post operative wound infections
Tidsram: 14 days
Compare for incidence of post operative wound infection among mothers that receive single dose versus multiple dose antibiotics
14 days

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
clinical endometritis
Tidsram: 14 days
Compare the incidence of clinical endometritis among mothers that receive single versus multiple dose antibiotics
14 days
febrile morbidity
Tidsram: 14 days
compare the incidence of post operative febrile morbidity among mothers that receive single versus multiple doses
14 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Makerere University

Utredare

  • Huvudutredare: Mugisa Alex Gideon, MBChB., Makerere University Collage of Health Sciences, Department of Obstetrics and Gynecology
  • Studierektor: Paul Kiondo, MD, MMeD,PhD, Makerere University Collage of Health Sciences, Department of Obstetrics and Gynecology
  • Studierektor: Imelda Namagembe, MD, MMeD, MPH, Mulago National Referral Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2015

Primärt slutförande (Faktisk)

1 februari 2016

Avslutad studie (Faktisk)

1 mars 2016

Studieregistreringsdatum

Först inskickad

7 april 2016

Först inskickad som uppfyllde QC-kriterierna

12 april 2016

Första postat (Uppskatta)

13 april 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

13 april 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 april 2016

Senast verifierad

1 april 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2013/HD07/658U

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