InfectionNCT04163679

Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

A study testing Vaginal Preparation in people with Infection and Obstetric Labor Complications, run by Womack Army Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

asdgf Read more about this study

Who is it for?: Ages 18 to 64 years, women onlyHealthy volunteers can take part
Conditions the study is for: Infection, Obstetric Labor Complications, Endometritis
What is being tested?: Vaginal Preparation
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 1 siteUnited States
Study dates: 18 Sep 2019to 30 Jul 2021
Phase: Interventional
Are there results?: None posted in the registry

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 18 to 64 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

full term pregnancy
undergoing labored, non-emergent cesarean section
patient in labor

Who cannot join

Azithromycin contraindicated:
Known hypersensitivity to azithromycin, erythromycin, macrolides or ketolide medications.
liver dysfunction
Prescription medications which may interact with azithromycin, such as nelfinavir or warfarin
A history of a cardiac dysrhythmia (irregular heartbeats)
Known hypersensitivity to iodine

Show all 10Show fewer

Patients carrying fetuses with known congenital anomalies
Immunodeficiency
Patients who are not in labor at the time of delivery
Non-english speaking subjects or subjects with language barriers

Trial locations and contacts

1 site in 1 country.

United States1 site

Womack Army Medical Center
Fort Bragg, North Carolina, 28310

Other trials in United States

About this study

Official title: Combining Vaginal Preparation and Azithromycin in Reduction of Post Cesarean Infections: A Randomized Controlled Trial

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Read the detailed description

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Conditions: Infection, Obstetric Labor Complications, Endometritis, Cesarean Delivery Affecting Fetus, Wounds Injuries
Being tested: Vaginal Preparation
Medical subject headings: Infections, Obstetric Labor Complications, Endometritis, Wounds and Injuries

What participants receive

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

Vaginal PreparationProcedure or surgery
One sponge stick will be inserted into the vagina, where it will stay during the scrubbing of thighs and genitals.
One sponge will be used to scrub the right inner thigh from mid-thigh to right labia majora. This sponge will then be discarded.
A second sponge will be used to scrub the left inner thigh from mid-thigh to left labia majora. This sponge will then be discarded.
A third sponge will be used to scrub the mons pubs, labia majora and minor, perineum and rectum in that order then will be discarded. This will be repeated with a fourth sponge.
The existing sponge stick in the vagina will be rotated in the vagina twice then removed. This will be discarded.
A second sponge stick will be inserted in the vagina, rotated twice then removed. As it is removed from the vagina, the perineum and rectum will be swabbed with the stick in that order then discarded. This will be repeated using a third sponge stick.

Study groups in NCT04163679
Study group	Role	What they receive
Vaginal Preparation	Experimental	In addition to standard care, subjects will undergo vaginal preparation (VP). A VP kit includes sponge sticks and sponges soaked in a povidone-iodine 10% solution. Receives: Procedure: Vaginal Preparation
Standard Infection Procedures	Sham comparator	The very staff will follow hospital protocols for the cesarean delivery. The subject and the infant will be provided care in accordance with current medical standards and be discharged at the discretion of the attending physician. Receives: Procedure: Vaginal Preparation

What is being measured

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

Infection rates
wound infection
Measured: Six weeks postpartum
Infection rates
endometritis
Measured: six weeks postpartum

Secondary outcomes (7)

Infant Birth Weight
record their birth weight (gm)
Measured: Four weeks after birth
Infant Apgar scores
Apgar scores
Measured: Four weeks after birth
Infant Length of hospital stay
Hospital stay (days)
Measured: Four weeks after birth
Numbers of Infants admitted to NICU
Infant admission to neonatal intensive care unit
Measured: four weeks after birth
Number of Infants that develop respiratory distress
The infant acquiring the condition of respiratory distress
Measured: Four weeks after birth
Number of Infants that develop sepsis
Infant acquiring sepsis
Measured: Four weeks after birth
Number of infants that die
Infant death
Measured: Four weeks after birth

Timeline

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

18 Sep 201930 Jul 2021

First posted15 Nov 2019
Study start18 Sep 2019
Primary completion30 Jul 2021
Study completion30 Jul 2021

Why it stopped: Enrollment issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04163679
Sponsor's protocol ID: RHC-A-19-033
Status last verified: Oct 2021
First submitted: 8 Nov 2019
Last updated: 11 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Mackeen AD, Packard RE, Ota E, Berghella V, Baxter JK. Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery. Cochrane Database Syst Rev. 2014 Dec 5;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2.
PubMed 25479008
Conroy K, Koenig AF, Yu YH, Courtney A, Lee HJ, Norwitz ER. Infectious morbidity after cesarean delivery: 10 strategies to reduce risk. Rev Obstet Gynecol. 2012;5(2):69-77.
PubMed 22866185
Tita AT, Szychowski JM, Boggess K, Saade G, Longo S, Clark E, Esplin S, Cleary K, Wapner R, Letson K, Owens M, Abramovici A, Ambalavanan N, Cutter G, Andrews W; C/SOAP Trial Consortium. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2016 Sep 29;375(13):1231-41. doi: 10.1056/NEJMoa1602044.
PubMed 27682034
Tuuli MG, Liu L, Longman RE, Odibo AO, Macones GA, Cahill AG. Infectious morbidity is higher after second-stage compared with first-stage cesareans. Am J Obstet Gynecol. 2014 Oct;211(4):410.e1-6. doi: 10.1016/j.ajog.2014.03.040. Epub 2014 Mar 18.
PubMed 24657794
Kawakita T, Landy HJ. Surgical site infections after cesarean delivery: epidemiology, prevention and treatment. Matern Health Neonatol Perinatol. 2017 Jul 5;3:12. doi: 10.1186/s40748-017-0051-3. eCollection 2017.
PubMed 28690864
Tita AT, Hauth JC, Grimes A, Owen J, Stamm AM, Andrews WW. Decreasing incidence of postcesarean endometritis with extended-spectrum antibiotic prophylaxis. Obstet Gynecol. 2008 Jan;111(1):51-6. doi: 10.1097/01.AOG.0000295868.43851.39.
PubMed 18165392
Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3.
PubMed 25350672
Caissutti C, Saccone G, Zullo F, Quist-Nelson J, Felder L, Ciardulli A, Berghella V. Vaginal Cleansing Before Cesarean Delivery: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Sep;130(3):527-538. doi: 10.1097/AOG.0000000000002167.
PubMed 28796683
Skeith AE, Niu B, Valent AM, Tuuli MG, Caughey AB. Adding Azithromycin to Cephalosporin for Cesarean Delivery Infection Prophylaxis: A Cost-Effectiveness Analysis. Obstet Gynecol. 2017 Dec;130(6):1279-1284. doi: 10.1097/AOG.0000000000002333.
PubMed 29112658
American College of Obstetricians and Gynecologists Women's Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: Solutions for surgical preparation of the vagina. Obstet Gynecol. 2013 Sep;122(3):718-20. doi: 10.1097/01.AOG.0000433982.36184.95.
PubMed 23963423
Reid VC, Hartmann KE, MCMahon M, Fry EP. Vaginal preparation with povidone iodine and postcesarean infectious morbidity: a randomized controlled trial. Obstet Gynecol. 2001 Jan;97(1):147-52. doi: 10.1016/s0029-7844(00)01087-5.
PubMed 11152924
Dalton E, Castillo E. Post partum infections: A review for the non-OBGYN. Obstet Med. 2014 Sep;7(3):98-102. doi: 10.1177/1753495X14522784. Epub 2014 Feb 27.
PubMed 27512432
Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017.
PubMed 28255256
Haas DM, Morgan S, Contreras K, Enders S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2018 Jul 17;7(7):CD007892. doi: 10.1002/14651858.CD007892.pub6.
PubMed 30016540
Kawakita T, Iqbal SN, Desale S, Fries M. Decrease in surgical site infection after cesarean delivery by implementing surgical bundle. Am J Obstet Gynecol 2018; 218:S323-S323.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combining Vaginal Preparation and Azithromycin in Reduction of Post Cesarean Infections: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04163679
Acronym / sponsor ID: RHC-A-19-033
Conditions: Infection, Obstetric Labor Complications, Endometritis, Cesarean Delivery Affecting Fetus, Wounds Injuries
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment issues
Enrolment: 84 participants (actual)
Lead sponsor: Womack Army Medical CenterUS federal agency
Study start: 18 Sep 2019 (actual)
Primary completion: 30 Jul 2021 (actual)
Study completion: 30 Jul 2021 (actual)
First posted: 15 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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Detailed description

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Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Vaginal Preparation	Experimental	Procedure: Vaginal PreparationIn addition to standard care, subjects will undergo vaginal preparation (VP). A VP kit includes sponge sticks and sponges soaked in a povidone-iodine 10% solution.
Standard Infection Procedures	Sham comparator	Procedure: Vaginal PreparationThe very staff will follow hospital protocols for the cesarean delivery. The subject and the infant will be provided care in accordance with current medical standards and be discharged at the discretion of the attending physician.

Who may qualify

Ages: 18 to 64 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

full term pregnancy
undergoing labored, non-emergent cesarean section
patient in labor

Key exclusion criteria (10 listed)

Known hypersensitivity to azithromycin, erythromycin, macrolides or ketolide medications.
liver dysfunction
Prescription medications which may interact with azithromycin, such as nelfinavir or warfarin
A history of a cardiac dysrhythmia (irregular heartbeats)
Known hypersensitivity to iodine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vaginal PreparationOne sponge stick will be inserted into the vagina, where it will stay during the scrubbing of thighs and genitals. One sponge will be used to scrub the right inner thigh from mid-thigh to right labia majora. This sponge will then be discarded. A second sponge will be used to scrub the left inner thigh from mid-thigh to left labia majora. This sponge will then be discarded. A third sponge will be used to scrub the mons pubs, labia majora and minor, perineum and rectum in that order then will be discarded. This will be repeated with a fourth sponge. The existing sponge stick in the vagina will be rotated in the vagina twice then removed. This will be discarded. A second sponge stick will be inserted in the vagina, rotated twice then removed. As it is removed from the vagina, the perineum and rectum will be swabbed with the stick in that order then discarded. This will be repeated using a third sponge stick.	Procedure or surgery	Standard Infection Procedures, Vaginal Preparation

Primary outcome

Infection rates
Time frame: Six weeks postpartum
wound infection
Infection rates
Time frame: six weeks postpartum
endometritis

7 secondary outcomes

Infant Birth Weight
Time frame: Four weeks after birth
Infant Apgar scores
Time frame: Four weeks after birth
Infant Length of hospital stay
Time frame: Four weeks after birth
Numbers of Infants admitted to NICU
Time frame: four weeks after birth
Number of Infants that develop respiratory distress
Time frame: Four weeks after birth
Number of Infants that develop sepsis
Time frame: Four weeks after birth
Number of infants that die
Time frame: Four weeks after birth

Results and safety

The study was stopped early (reason given: Enrollment issues). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
Background: PubMed 25479008Mackeen AD, Packard RE, Ota E, Berghella V, Baxter JK. Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery. Cochrane Database Syst Rev. 2014 Dec 5;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2.
Results publication: PubMed 22866185Conroy K, Koenig AF, Yu YH, Courtney A, Lee HJ, Norwitz ER. Infectious morbidity after cesarean delivery: 10 strategies to reduce risk. Rev Obstet Gynecol. 2012;5(2):69-77.
Results publication: PubMed 27682034Tita AT, Szychowski JM, Boggess K, Saade G, Longo S, Clark E, Esplin S, Cleary K, Wapner R, Letson K, Owens M, Abramovici A, Ambalavanan N, Cutter G, Andrews W; C/SOAP Trial Consortium. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2016 Sep 29;375(13):1231-41. doi: 10.1056/NEJMoa1602044.
Results publication: PubMed 24657794Tuuli MG, Liu L, Longman RE, Odibo AO, Macones GA, Cahill AG. Infectious morbidity is higher after second-stage compared with first-stage cesareans. Am J Obstet Gynecol. 2014 Oct;211(4):410.e1-6. doi: 10.1016/j.ajog.2014.03.040. Epub 2014 Mar 18.
Results publication: PubMed 28690864Kawakita T, Landy HJ. Surgical site infections after cesarean delivery: epidemiology, prevention and treatment. Matern Health Neonatol Perinatol. 2017 Jul 5;3:12. doi: 10.1186/s40748-017-0051-3. eCollection 2017.
Results publication: PubMed 18165392Tita AT, Hauth JC, Grimes A, Owen J, Stamm AM, Andrews WW. Decreasing incidence of postcesarean endometritis with extended-spectrum antibiotic prophylaxis. Obstet Gynecol. 2008 Jan;111(1):51-6. doi: 10.1097/01.AOG.0000295868.43851.39.
Results publication: PubMed 25350672Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3.
Results publication: PubMed 28796683Caissutti C, Saccone G, Zullo F, Quist-Nelson J, Felder L, Ciardulli A, Berghella V. Vaginal Cleansing Before Cesarean Delivery: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Sep;130(3):527-538. doi: 10.1097/AOG.0000000000002167.
Results publication: PubMed 29112658Skeith AE, Niu B, Valent AM, Tuuli MG, Caughey AB. Adding Azithromycin to Cephalosporin for Cesarean Delivery Infection Prophylaxis: A Cost-Effectiveness Analysis. Obstet Gynecol. 2017 Dec;130(6):1279-1284. doi: 10.1097/AOG.0000000000002333.
Results publication: PubMed 23963423American College of Obstetricians and Gynecologists Women's Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: Solutions for surgical preparation of the vagina. Obstet Gynecol. 2013 Sep;122(3):718-20. doi: 10.1097/01.AOG.0000433982.36184.95.
Results publication: PubMed 11152924Reid VC, Hartmann KE, MCMahon M, Fry EP. Vaginal preparation with povidone iodine and postcesarean infectious morbidity: a randomized controlled trial. Obstet Gynecol. 2001 Jan;97(1):147-52. doi: 10.1016/s0029-7844(00)01087-5.
Results publication: PubMed 27512432Dalton E, Castillo E. Post partum infections: A review for the non-OBGYN. Obstet Med. 2014 Sep;7(3):98-102. doi: 10.1177/1753495X14522784. Epub 2014 Feb 27.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vaginal Preparation in people with Infection and Obstetric Labor Complications, run by Womack Army Medical Center at 1 site in United States.

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 10 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: stopped early, as of the sponsor's last update on 11 Oct 2021. 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 United States. 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.

Are results available for this study?

The study was stopped early (reason given: Enrollment issues). Results are not available in the source record.

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?

Infection rates (time frame: Six weeks postpartum). The study lists 2 primary outcomes in all. 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 NCT04163679, which also lists 16 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 11 Oct 2021.