Sponsor study identifier
interventional
756
1 country
1
Study Start
January 12, 2018
Actual (reported)Primary Completion
May 15, 2020
Actual (reported)Study Completion
October 1, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 25, 2017
Actual (reported)August 14, 2017
Actual (reported)January 12, 2018
Actual (reported)May 15, 2020
Actual (reported)October 1, 2020
Actual (reported)July 18, 2022
Actual (reported)Number of Participants Who Experienced Composite Peripartum Infection or Death
Maternal peripartum infection including chorioamnionitis, endometritis, wound infection/abscess, sepsis, and death
Up to 6 weeks after delivery
Number of Participants Who Experienced Pyelonephritis
Up to hospital discharge
Number of Participants Who Experienced Breast Infection
Up to 6 weeks after delivery
Number of Participants Who Experienced Other Infection
up to 6 weeks after delivery
Number of Participants Who Experienced Fever
up to 6 weeks after delivery
Number of Participants Who Experienced Hypothermia
up to 6 weeks after delivery
Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.
Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.
Azithromycin tablet
azithromycin and amoxicillin
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Azithromycin and amoxicillin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordCameroon Baptist Convention Health Services
Bamenda, Cameroon
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.
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.
Alan Tita, MD, PhD
University of Alabama at Birmingham
756 participants (actual enrollment reported by the registry).
First Submitted
July 25, 2017
First Posted
August 14, 2017
Study Start
January 12, 2018
Actual (reported)MORDOR II Burkina Faso: Longitudinal Trial
This 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)
Placebo tablet
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
May 15, 2020
Actual (reported)Study Completion
October 1, 2020
Actual (reported)Last Updated
July 18, 2022
Results First Posted
July 18, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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