Postpartum EndometritisPhase 1/2NCT04385680

Chlorhexidine Vaginal Preparation for Reduction of Post-cesarean Endometritis and Sepsis

A Phase 1/2 study testing Chlorhexidine Gluconate vaginal solution 0.05% in people with Postpartum Endometritis and Wound Infection, run by Zagazig University at 1 site in Saudi Arabia.

Completed

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

Official record

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Trial summary

The study aims to assess the beneficial value of vaginal preparation with chlorhexidine gluconate 0.05% before cesarean delivery of cases in labor in reduction of postoperative endometritis, fever and wound complications compared to no preparation or using saline only. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Postpartum Endometritis, Wound Infection, Chlorhexidine Adverse Reaction
What is being tested?: Chlorhexidine Gluconate vaginal solution 0.05%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 840 participants
Where: 1 siteSaudi Arabia
Study dates: 15 May 2020to 30 Aug 2022
Phase: Phase 1/2
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Gestational age ≥28 weeks.
Cases had cesarean section after start of labor.

Who cannot join

Women with known allergy to chlorhexidine gluconate or any of its ingredients.
Women with diagnosed group B streptococcus (GBS) colonization.
Women with active infection during the procedure.
Women did not receive the standard preoperative antibiotic prophylaxis.
Women with diagnosis of chorioamnionitis.
Prolonged rupture of membranes >7 days

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

Armed Forces Hospitals Southern Region
Khamis Mushait, 62411

Other trials in Saudi Arabia

About this study

Official title: The Impact of Chlorhexidine Preoperative Vaginal Preparation in Reducing the Post-cesarean Endometritis and Sepsis for Cases in Labor. A Randomized Controlled Trial

Read the detailed description

Despite the demonstrated effectiveness of the vaginal cleansing in the previous study, yet this has not been adopted within obstetric practice internationally and does not feature within the NICE Intrapartum guideline.7 This is may be due to concerns with exposure of the fetus to iodine-based substances, concerns with vaginal staining and allergy to iodine. Iodine is an antibacterial agent, but becomes inactive by the presence of blood may limit its use.

Chlorhexidine show greater reduction in skin flora after application compared with povidone-iodine agents (0.5 and 4%) respectively and has a greater residual activity after application than other preparations and (unlike povidone iodine) it is not inactivated by the presence of blood. Thus, there are a number of reasons to believe that vaginal cleansing with chlorhexidine would be an appropriate alternative to povidone iodine.8 There is one RCT comparing povidone iodine with chlorhexidine gluconate for vaginal cleansing at CS. This suggested that chlorhexidine may be superior, and further research was needed.9 Solutions that contain lower concentrations, such as chlorhexidine gluconate and acetate (0.05%) are usually well tolerated and may be used for vaginal preparation. With this preparation, there are no reported cases of allergy.8 Importantly, no safety concerns for the mother or baby have been identified with chlorhexidine gluconate used for vaginal cleansing.10

Conditions: Postpartum Endometritis, Wound Infection, Chlorhexidine Adverse Reaction, Postoperative Fever
Being tested: Chlorhexidine Gluconate vaginal solution 0.05%
Keywords: post-cesarean endometritis, wound infection, chlorhexidine vaginal preparation, chlorhexidine adverse reaction
Medical subject headings: Wound Infection

What participants receive

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

Chlorhexidine Gluconate vaginal solution 0.05%Drug
Also called No preparation or preparation with saline only
preoperative vaginal preparation

Study groups in NCT04385680
Study group	Role	What they receive
Chlorhexidine vaginal prep.arm	Experimental	Women in labor who will receive vaginal cleaning immediately before cesarean section using 50 ml of chlorhexidine gluconate 0.05% solution and standard abdominal scrub with chlorhexidine gluconate 4%. This concentration is indicated within the British National Formulary for swabbing in obstetrics. A swab soaked in the antiseptic will be used to clean the vagina for 30 seconds prior to CS at the time of urinary catheter insertion by long forceps. After the CS procedure, the vagina is always cleaned of excess blood as with a dry swab. Receives: Drug: Chlorhexidine Gluconate vaginal solution 0.05%
No vaginal antiseptic arm	No intervention	Women in labor who will receive abdominal scrub with chlorhexidine gluconate 4% only. Vaginal preparation is not including antiseptic or using normal saline only.

What is being measured

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

post-cesarean endometritis
uterine fundal tenderness on bimanual examination ( physical examination: suprapubic tenderness, pain elicited by cervical motion, tenderness in parametrium, all during bimanual examination) + with fever (An oral temperature of 38°C or higher within the first 10 days postpartum or 38.7°C within the first 24 hours postpartum) ± purulent lochia requiring antibiotic therapy ( initial antibiotic will be started then waiting for proper therapy according to culture and sensitivity
Measured: First 10 days post-cesarean
Postoperative wound infection
erythema, warmth, tenderness, purulent drainage from the incision site, with or without fever, requiring antibiotic therapy.
Measured: First month after cesarean

Secondary outcomes (4)

Significant leukocytosis
increase of WBCs count > 50% from preoperative count
Measured: First 10 days postcesarean
Chlorhexidine adverse drug reaction
maternal or neonatal allergy or irritation
Measured: First 10 days
incidence of hospital readmission
percent of cases needed readmission in both arms
Measured: One month
length of hospital stay
duration of hospitalization due to endometritis
Measured: One month

Timeline

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

15 May 202030 Aug 2022

First posted13 May 2020
Study start15 May 2020
Primary completion10 Mar 2022
Study completion30 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Postpartum EndometritisStudies of the same condition, open and under way.
More trials run by Zagazig UniversityThe sponsor's other registered studies.
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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 840 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04385680
Sponsor's protocol ID: chlorhex. post cs endometritis
Status last verified: Sep 2022
First submitted: 9 May 2020
Last updated: 23 Sep 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
PubMed 26849801
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
Atia H, Saleh A, Ibrahim M, Shafik A. Efficacy of chlorhexidine vaginal preparation in reducing postoperative infections during emergency cesarean deliveries for women in labor: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Oct 28;26(1):1267. doi: 10.1186/s12884-026-10027-1.
PubMed 42983692

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Chlorhexidine Preoperative Vaginal Preparation in Reducing the Post-cesarean Endometritis and Sepsis for Cases in Labor. A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04385680
Acronym / sponsor ID: chlorhex. post cs endometritis
Conditions: Postpartum Endometritis, Wound Infection, Chlorhexidine Adverse Reaction, Postoperative Fever
Keywords: post-cesarean endometritis, wound infection, chlorhexidine vaginal preparation, chlorhexidine adverse reaction
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 840 participants (actual)
Lead sponsor: Zagazig UniversityOther government
Study start: 15 May 2020 (actual)
Primary completion: 10 Mar 2022 (actual)
Study completion: 30 Aug 2022 (actual)
First posted: 13 May 2020 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Chlorhexidine vaginal prep.arm	Experimental	Drug: Chlorhexidine Gluconate vaginal solution 0.05%Women in labor who will receive vaginal cleaning immediately before cesarean section using 50 ml of chlorhexidine gluconate 0.05% solution and standard abdominal scrub with chlorhexidine gluconate 4%. This concentration is indicated within the British National Formulary for swabbing in obstetrics. A swab soaked in the antiseptic will be used to clean the vagina for 30 seconds prior to CS at the time of urinary catheter insertion by long forceps. After the CS procedure, the vagina is always cleaned of excess blood as with a dry swab.
No vaginal antiseptic arm	No intervention	–Women in labor who will receive abdominal scrub with chlorhexidine gluconate 4% only. Vaginal preparation is not including antiseptic or using normal saline only.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Gestational age ≥28 weeks.
Cases had cesarean section after start of labor.

Key exclusion criteria (6 listed)

Women with known allergy to chlorhexidine gluconate or any of its ingredients.
Women with diagnosed group B streptococcus (GBS) colonization.
Women with active infection during the procedure.
Women did not receive the standard preoperative antibiotic prophylaxis.
Women with diagnosis of chorioamnionitis.

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
Chlorhexidine Gluconate vaginal solution 0.05%Also: No preparation or preparation with saline onlypreoperative vaginal preparation	Drug	Chlorhexidine vaginal prep.arm

Primary outcome

post-cesarean endometritis
Time frame: First 10 days post-cesarean
uterine fundal tenderness on bimanual examination ( physical examination: suprapubic tenderness, pain elicited by cervical motion, tenderness in parametrium, all during bimanual examination) + with fever (An oral temperature of 38°C or higher within the first 10 days postpartum or 38.7°C within the first 24 hours postpartum) ± purulent lochia requiring antibiotic therapy ( initial antibiotic will be started then waiting for proper therapy according to culture and sensitivity
Postoperative wound infection
Time frame: First month after cesarean
erythema, warmth, tenderness, purulent drainage from the incision site, with or without fever, requiring antibiotic therapy.

4 secondary outcomes

Significant leukocytosis
Time frame: First 10 days postcesarean
Chlorhexidine adverse drug reaction
Time frame: First 10 days
incidence of hospital readmission
Time frame: One month
length of hospital stay
Time frame: One month

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 23 Sep 2022.
Background: PubMed 26849801Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
Background: PubMed 28255256Zuarez-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.
Background: PubMed 30016540Haas 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.
Derived from this study: PubMed 42983692Atia H, Saleh A, Ibrahim M, Shafik A. Efficacy of chlorhexidine vaginal preparation in reducing postoperative infections during emergency cesarean deliveries for women in labor: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Oct 28;26(1):1267. doi: 10.1186/s12884-026-10027-1.
Individual participant dataSharing planned: No

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.

Ahmed Shafiek principal investigator

Armed forces hospitals Southern Region KSA

Hytham Atia principal investigator

Armed Forces Hospitals Southern Region

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Chlorhexidine Gluconate vaginal solution 0.05% in people with Postpartum Endometritis and Wound Infection, run by Zagazig University at 1 site in Saudi Arabia.

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 2 inclusion and 6 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 23 Sep 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 Saudi Arabia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

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?

post-cesarean endometritis (time frame: First 10 days post-cesarean). 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 NCT04385680, which also lists 4 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 23 Sep 2022.