AzTrials
AzTrials

Postpartum SepsisPhase 4NCT03248297

Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries

A Phase 4 study testing Azithromycin and Azithromycin and amoxicillin in people with Postpartum Sepsis and Postpartum Endometritis, run by University of Alabama at Birmingham at 1 site in Cameroon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon, Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor ≥ 18 hours to identical oral regimens of 1 gram of azithromycin, 1 gram of azithromycin+2 grams of amoxicillin or placebo. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
What is being tested?
Azithromycin and Azithromycin and amoxicillin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
756 participants
Where
1 siteCameroon
Study dates
12 Jan 2018to 1 Oct 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Women ≥ 37 weeks' viable singleton or twin gestation in labor planning a vaginal delivery with
  • Prolonged membrane rupture (≥8 hours) or
  • Prolonged labor (≥18 hours).

Who cannot join

  • Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization: because standard antibiotic therapy for these conditions may confound trial intervention.
  • Allergy to azithromycin or amoxicillin
  • Plan for cesarean delivery prior to enrollment
  • Fetal demise or major congenital anomaly: Major congenital anomalies may confound assessment of neonatal outcomes and every attempt will be made up front to exclude them from randomization. However, some unrecognized fetal anomalies may inevitably be randomized. These will not be excluded post-randomization from the primary (maternal outcome) analysis; they will be taken into consideration in the secondary analyses of neonatal outcomes.

Trial locations and contacts

1 site in 1 country.

Cameroon1 site

  • Cameroon Baptist Convention Health Services

    Bamenda

Other trials in Cameroon

About this study

Official title: Azithromycin With or Without Amoxicillin to Prevent Peripartum Infection and Sepsis in Laboring High-risk Women: 3-Arm RCT

This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon, Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor ≥ 18 hours to identical oral regimens of 1 gram of azithromycin, 1 gram of azithromycin+2 grams of amoxicillin or placebo. Women will be followed to ascertain maternal infectious outcomes and perinatal outcomes.

Read the detailed description

This 3-arm study is a large randomized clinical trial designed to evaluate the comparative effectiveness and safety of single dose oral azithromycin or combined azithromycin+amoxicillin compared to placebo for the prevention of peripartum infections and sepsis in laboring women. We have previously shown the effectiveness of azithromycin for extended spectrum antibiotic prophylaxis in addition to the standard cephalosporin alone for reduction of post-cesarean infections. In LICs, the fraction of maternal infection and sepsis from cesarean delivery is minimal. Therefore, it is necessary to evaluate strategies aimed at reducing these morbidities in women who have vaginal births. There is an increased risk of infection in women who have prolonged labor or prolonged rupture of membranes. Drawing from our findings with azithromycin-based extended antibiotic prophylaxis for cesarean delivery, we propose to adapt the intervention and evaluate a single oral dose of azithromycin (with or without oral amoxicillin) to prevent maternal peripartum infection and sepsis. This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon, Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor ≥18 hours to 1 gram of oral azithromycin, 1 gram of azithromycin+2 grams of amoxicillin, compared to usual care (placebo). Women will be followed to ascertain maternal infectious outcomes and perinatal outcomes.

Being tested
Azithromycin, Azithromycin and amoxicillin, Placebo
Medical subject headings
Puerperal Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzithromycinDrug

    Azithromycin tablet

  • Azithromycin and amoxicillinDrug

    Also called azithromycin, amoxicillin

    azithromycin and amoxicillin

  • PlaceboDrug

    Placebo tablet

Study groups in NCT03248297
Study groupRoleWhat they receive
Azithromycin and amoxicillin placeboExperimentalPatients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.
Receives: Drug: Azithromycin; Drug: Placebo
Azithromycin + amoxicillinExperimentalPatients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.
Receives: Drug: Azithromycin and amoxicillin
Usual CarePlacebo comparatorThis arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experienced Composite Peripartum Infection or Death

    Maternal peripartum infection including chorioamnionitis, endometritis, wound infection/abscess, sepsis, and death

    Measured: Up to 6 weeks after delivery

Secondary outcomes (11)

  1. Number of Participants Who Experienced Pyelonephritis

    Other Infections

    Measured: Up to hospital discharge

  2. Number of Participants Who Experienced Breast Infection

    Other infections

    Measured: Up to 6 weeks after delivery

  3. Number of Participants Who Experienced Other Infection

    Includes Hepatitis B, thyroid infection, vaginal infection, viral infection, leg cellulitis, unknown abdominal infection,malaria

    Measured: up to 6 weeks after delivery

  4. Number of Participants Who Experienced Fever

    Any fever higher than 38C

    Measured: up to 6 weeks after delivery

  5. Number of Participants Who Experienced Hypothermia

    Any hypothermia less than 36C

    Measured: up to 6 weeks after delivery

  6. Number of Participants Who Needed PP Antibiotic

    Any postpartum antibiotic

    Measured: up to 6 weeks after delivery

  7. Number of Participants Who Experienced Transfusion

    Blood transfusion

    Measured: up to 6 weeks after delivery

  8. Number of Participants Who Experienced Stillbirth

    Any stillbirth

    Measured: delivery

  9. Length of Stay

    Length of stay in days

    Measured: up to 6 weeks postpartum

  10. Number of Participants Who Experienced a Clinic Visit

    Clinic visit after discharge

    Measured: up to 6 weeks after delivery

  11. Number of Participants Who Experienced a Maternal Readmission

    Maternal readmission

    Measured: up to 6 weeks after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2017
  2. Study start12 Jan 2018
  3. Primary completion15 May 2020
  4. Study completion1 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
756 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03248297
Sponsor's protocol ID
CHI UAB MISP # 54628
Status last verified
Mar 2022
First submitted
25 Jul 2017
Last updated
18 Jul 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.

    PubMed 10196487

  • ASHP Therapeutic Guidelines on Antimicrobial Prophylaxis in Surgery. American Society of Health-System Pharmacists. Am J Health Syst Pharm. 1999 Sep 15;56(18):1839-88. doi: 10.1093/ajhp/56.18.1839. No abstract available.

    PubMed 10511234

  • Tita ATN, Boggess K, Saade G. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2017 Jan 12;376(2):182. doi: 10.1056/NEJMc1614626. No abstract available.

    PubMed 28076707

  • WHO. WHO recommendations for prevention and treatment of maternal peripartum infections. Sept 2015 http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/peripartum-infections-guidelines/en/

  • Subramaniam A, Ye Y, Mbah R, Mbunwe DM, Pekwarake S, Bunwi EY, Fondzeyuf A, Ngong MG, Dionne-Odom J, Harper LM, Jauk VC, Carlo WA, Halle-Ekane G, Szychowski JM, Tih P, Tita AT. Single Dose of Oral Azithromycin With or Without Amoxicillin to Prevent Peripartum Infection in Laboring, High-Risk Women in Cameroon: A Randomized Controlled Trial. Obstet Gynecol. 2021 Nov 1;138(5):703-713. doi: 10.1097/AOG.0000000000004565.

    PubMed 34619734

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Azithromycin and Azithromycin and amoxicillin in people with Postpartum Sepsis and Postpartum Endometritis, run by University of Alabama at Birmingham at 1 site in Cameroon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced Composite Peripartum Infection or Death (time frame: Up to 6 weeks after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03248297, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in