Operation Wound; InfectionNCT03442218
Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section
A study testing Clorhexidine and Saline solution in people with Operation Wound; Infection and Endometritis, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Operation Wound; Infection, Endometritis
- What is being tested?
- Clorhexidine and Saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 1 sitePanama
- Study dates
- 1 Jun 2017to 28 Feb 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with gestation between 34 and 41 6/7 weeks.
- Premature rupture of membranes (> 6 hours).
- Use of prophylactic antibiotic 1 hour previous to cesarean section.
Who cannot join
- Any source of infection diagnosed previous to surgery.
- Fever of unknown origin previous to surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use fo Antiseptic Solution for Vaginal Wash Before Cesarean Section in Patients With Premature Rupture of Membranes. A Randomized, Double Blind, Controlled Trial.
To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).
- Conditions
- Operation Wound; Infection, Endometritis
- Being tested
- Clorhexidine, Saline solution
- Keywords
- Cesarean, Operative site infection, Vaginal wash, Clorhexidine, Endometritis
- Medical subject headings
- Surgical Wound Infection, Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClorhexidineDrug
Vaginal wash with clorhexidine solution previous to cesarean section in patients with premature rupture of membranes.
Saline solutionDrug
Vaginal wash with saline solution previous to cesarean section in patients with premature rupture of membranes.
| Study group | Role | What they receive |
|---|---|---|
| Clorhexidine | Experimental | Vaginal wash with clorhexidine solution Receives: Drug: Clorhexidine |
| Saline solution | Placebo comparator | Vaginal wash with saline solution Receives: Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of endometritis after cesarean section
Endometritis
Measured: 15 days
Secondary outcomes (2)
Number of cases of cesarean site infection
Operative site infection
Measured: 15 days
Number of cases of fever (38°C or above) in the puerperium
Puerperal fever
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Jun 2017
- Primary completion31 Aug 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Operation Wound; 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Collaborators
- Sistema Nacional de Investigación (SNI) - Panamá
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442218
- Sponsor's protocol ID
- MHST2014-20
- Status last verified
- Dec 2019
- First submitted
- 13 Feb 2018
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Urena N, Reyes O. Preoperative vaginal cleansing with chlorhexidine vs placebo in patients with rupture of membranes: a prospective, randomized, double-blind, placebo-control study. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100572. doi: 10.1016/j.ajogmf.2022.100572. Epub 2022 Jan 17.
PubMed 35051671Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
PubMed 32335895
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use fo Antiseptic Solution for Vaginal Wash Before Cesarean Section in Patients With Premature Rupture of Membranes. A Randomized, Double Blind, Controlled Trial.
- ClinicalTrials.gov ID
- NCT03442218
- Acronym / sponsor ID
- MHST2014-20
- Conditions
- Operation Wound; Infection, Endometritis
- Keywords
- Cesarean, Operative site infection, Vaginal wash, Clorhexidine, Endometritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Collaborators
- Sistema Nacional de Investigación (SNI) - Panamá
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 22 Feb 2018 (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.
To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clorhexidine | Experimental | Drug: ClorhexidineVaginal wash with clorhexidine solution |
| Saline solution | Placebo comparator | Drug: Saline solutionVaginal wash with saline solution |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women with gestation between 34 and 41 6/7 weeks.
- Premature rupture of membranes (> 6 hours).
- Use of prophylactic antibiotic 1 hour previous to cesarean section.
Key exclusion criteria (2 listed)
- Any source of infection diagnosed previous to surgery.
- Fever of unknown origin previous to surgery.
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 |
|---|---|---|
| ClorhexidineVaginal wash with clorhexidine solution previous to cesarean section in patients with premature rupture of membranes. | Drug | Clorhexidine |
| Saline solutionVaginal wash with saline solution previous to cesarean section in patients with premature rupture of membranes. | Drug | Saline solution |
Primary outcome
Number of cases of endometritis after cesarean section
Time frame: 15 days
Endometritis
2 secondary outcomes
Number of cases of cesarean site infection
Time frame: 15 days
Number of cases of fever (38°C or above) in the puerperium
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Derived from this study: PubMed 35051671Urena N, Reyes O. Preoperative vaginal cleansing with chlorhexidine vs placebo in patients with rupture of membranes: a prospective, randomized, double-blind, placebo-control study. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100572. doi: 10.1016/j.ajogmf.2022.100572. Epub 2022 Jan 17.
- Derived from this study: PubMed 32335895Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
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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 Clorhexidine and Saline solution in people with Operation Wound; Infection and Endometritis, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 2 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 9 Dec 2019. 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 Panama. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cases of endometritis after cesarean section (time frame: 15 days). 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 NCT03442218, which also lists 2 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 9 Dec 2019.