EpisiotomyLA30051990NCT06978049
Use of Lactic Acid Gel for Intravaginal Use, 7 Applicators x 5ml, Bayer to Reduce Post-episiotomy Discomfort
A study testing Topical Lactic Acid Gel (BAYER) in people with Episiotomy and Wound Healing, run by Saint Andrew Hospital Constanta at 1 site in Romania.
Trial summary
This prospective controlled study evaluates the efficacy of topical lactic acid gel in enhancing episiotomy wound healing and improving postpartum sexual quality of life. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy, Wound Healing, Postpartum Period
- What is being tested?
- Topical Lactic Acid Gel (BAYER)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 31 Jan 2023to 31 Dec 2023
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-40 years
- Spontaneous vaginal delivery with mediolateral episiotomy at 38-40 weeks gestation
- No pre-existing wound healing disorders or infections
- Provided informed consent
Who cannot join
- Known hypersensitivity to lactic acid products
- Third- or fourth-degree perineal tears
- Gestational diabetes or immunosuppressive conditions
- Use of additional wound care treatments
Trial locations and contacts
1 site in 1 country.
About this study
This prospective controlled study evaluates the efficacy of topical lactic acid gel in enhancing episiotomy wound healing and improving postpartum sexual quality of life.
Read the detailed description
This prospective controlled clinical study aims to evaluate the efficacy of topical lactic acid gel in promoting the healing of episiotomy wounds and improving postpartum sexual quality of life.
The study was conducted at the County Clinical Emergency Hospital "Sf. Ap. Andrei" in Constanța, Romania, between February 1, 2023, and December 31, 2024, with ethical approvals obtained from both the Ethics Committee of Ovidius University of Constanța (No. 01/20.01.2023) and the Saint Andrew Hospital Ethics Committee (No. 7230/31.01.2023).
A total of 100 postpartum women aged 18 to 40 years, who underwent spontaneous vaginal delivery with mediolateral episiotomy at a gestational age of 38-40 weeks, were enrolled in the study after providing informed consent. Participants were sequentially assigned into two parallel groups:
Experimental Group (n = 50): Received topical lactic acid gel (commercially available formulation from BAYER, Bucharest, Romania) applied once daily directly to the episiotomy site, starting seven days postpartum, for a total duration of seven consecutive days.
Control Group (n = 50): Received standard postpartum care without additional topical treatments, allowing for spontaneous healing of the episiotomy wound.
The primary endpoint was the assessment of episiotomy wound healing quality at 40 days postpartum, determined via visual inspection and healing scoring. The secondary endpoint was the evaluation of postpartum sexual function, assessed using a validated 12-item sexual quality of life questionnaire specifically designed for postpartum women. The questionnaire addressed domains including sexual desire, orgasm frequency, sexual satisfaction, pain during intercourse (dyspareunia), vaginal dryness, emotional well-being during intercourse, and partner-related factors. Higher total scores reflected better sexual health and satisfaction.
- Conditions
- Episiotomy, Wound Healing, Postpartum Period
- Being tested
- Topical Lactic Acid Gel (BAYER)
- Keywords
- Episiotomy, Wound Healing, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Lactic Acid Gel (BAYER)Drug
Lactic acid gel, applied topically once daily to the episiotomy site, starting on postpartum day 7 for a total of seven consecutive days. Commercial product: BAYER (Bucharest, Romania).
| Study group | Role | What they receive |
|---|---|---|
| Canesbalance Group | Experimental | Participants in this group received topical lactic acid gel (a commercial product from BAYER, Bucharest, Romania) applied once daily directly to the episiotomy site. Treatment began on day 7 postpartum and continued for seven consecutive days. Receives: Drug: Topical Lactic Acid Gel (BAYER) |
| No Intervention Group | No intervention | Participants in this group received standard postpartum care without the addition of lactic acid gel or any other specific wound-healing treatments. Healing occurred spontaneously according to routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episiotomy Wound Healing Score at 40 Days Postpartum
Evaluation of the quality of episiotomy wound healing, assessed through visual inspection and clinical scoring at 40 days postpartum. Higher scores reflect better wound healing. Healing assessment was performed by the clinical care team using a standardized evaluation system to ensure consistency across participants.
Measured: 40 days postpartum
Secondary outcomes (1)
Increase in Quality of Sexual Life
Healing outcomes and sexual quality of life wIll be assessed 40 days postpartum using a 12-item questionnaire.
Measured: 40 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start31 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Andrew Hospital Constanta
- Sponsor type
- University, hospital or other
- Collaborators
- Ovidius University of Constanta
- Responsible party
- Principal investigator, Brezeanu Dragos, Ovidius University of Constanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978049
- Sponsor's protocol ID
- BD30051990
- Other IDs
- 7230/31.01.2023
- Acronym
- LA30051990
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study involves sensitive personal health information, including sexual function and postpartum recovery data, which are subject to strict confidentiality and privacy regulations. Participant consent for public data sharing was not obtained, and sharing of individual-level data may pose risks to participant anonymity. Only aggregate results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Lactic Acid Gel for Intravaginal Use, 7 Applicators x 5ml, Bayer to Reduce Post-episiotomy Discomfort
- ClinicalTrials.gov ID
- NCT06978049
- Acronym / sponsor ID
- LA30051990 / BD30051990
- Conditions
- Episiotomy, Wound Healing, Postpartum Period
- Keywords
- Episiotomy, Wound Healing, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saint Andrew Hospital ConstantaUniversity, hospital or other
- Collaborators
- Ovidius University of Constanta
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 May 2025 (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.
This prospective controlled study evaluates the efficacy of topical lactic acid gel in enhancing episiotomy wound healing and improving postpartum sexual quality of life.
Detailed description
This prospective controlled clinical study aims to evaluate the efficacy of topical lactic acid gel in promoting the healing of episiotomy wounds and improving postpartum sexual quality of life.
The study was conducted at the County Clinical Emergency Hospital "Sf. Ap. Andrei" in Constanța, Romania, between February 1, 2023, and December 31, 2024, with ethical approvals obtained from both the Ethics Committee of Ovidius University of Constanța (No. 01/20.01.2023) and the Saint Andrew Hospital Ethics Committee (No. 7230/31.01.2023).
A total of 100 postpartum women aged 18 to 40 years, who underwent spontaneous vaginal delivery with mediolateral episiotomy at a gestational age of 38-40 weeks, were enrolled in the study after providing informed consent. Participants were sequentially assigned into two parallel groups:
Experimental Group (n = 50): Received topical lactic acid gel (commercially available formulation from BAYER, Bucharest, Romania) applied once daily directly to the episiotomy site, starting seven days postpartum, for a total duration of seven consecutive days.
Control Group (n = 50): Received standard postpartum care without additional topical treatments, allowing for spontaneous healing of the episiotomy wound.
The primary endpoint was the assessment of episiotomy wound healing quality at 40 days postpartum, determined via visual inspection and healing scoring. The secondary endpoint was the evaluation of postpartum sexual function, assessed using a validated 12-item sexual quality of life questionnaire specifically designed for postpartum women. The questionnaire addressed domains including sexual desire, orgasm frequency, sexual satisfaction, pain during intercourse (dyspareunia), vaginal dryness, emotional well-being during intercourse, and partner-related factors. Higher total scores reflected better sexual health and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canesbalance Group | Experimental | Drug: Topical Lactic Acid Gel (BAYER)Participants in this group received topical lactic acid gel (a commercial product from BAYER, Bucharest, Romania) applied once daily directly to the episiotomy site. Treatment began on day 7 postpartum and continued for seven consecutive days. |
| No Intervention Group | No intervention | –Participants in this group received standard postpartum care without the addition of lactic acid gel or any other specific wound-healing treatments. Healing occurred spontaneously according to routine clinical practice. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-40 years
- Spontaneous vaginal delivery with mediolateral episiotomy at 38-40 weeks gestation
- No pre-existing wound healing disorders or infections
- Provided informed consent
Key exclusion criteria (4 listed)
- Known hypersensitivity to lactic acid products
- Third- or fourth-degree perineal tears
- Gestational diabetes or immunosuppressive conditions
- Use of additional wound care treatments
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 |
|---|---|---|
| Topical Lactic Acid Gel (BAYER)Lactic acid gel, applied topically once daily to the episiotomy site, starting on postpartum day 7 for a total of seven consecutive days. Commercial product: BAYER (Bucharest, Romania). | Drug | Canesbalance Group |
Primary outcome
Episiotomy Wound Healing Score at 40 Days Postpartum
Time frame: 40 days postpartum
Evaluation of the quality of episiotomy wound healing, assessed through visual inspection and clinical scoring at 40 days postpartum. Higher scores reflect better wound healing. Healing assessment was performed by the clinical care team using a standardized evaluation system to ensure consistency across participants.
1 secondary outcome
Increase in Quality of Sexual Life
Time frame: 40 days postpartum
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 18 May 2025.
- Individual participant dataSharing planned: No. The study involves sensitive personal health information, including sexual function and postpartum recovery data, which are subject to strict confidentiality and privacy regulations. Participant consent for public data sharing was not obtained, and sharing of individual-level data may pose risks to participant anonymity. Only aggregate results will be reported in publications.
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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 Topical Lactic Acid Gel (BAYER) in people with Episiotomy and Wound Healing, run by Saint Andrew Hospital Constanta at 1 site in Romania.
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 4 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 May 2025. 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 Romania. 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.
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?
Episiotomy Wound Healing Score at 40 Days Postpartum (time frame: 40 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2025.