SexualitySMDNCT03953573
Management of Post-delivery Pain and Its Impact on Resumption of Sexuality
An observational study of Sexuality and Delivery, run by Hopital Foch at 1 site in France.
Trial summary
Study of management of pain and information given to women post-delivery and their impact of the resumption of sexuality. Survey to be completed by women at 8 and 15 days and 1 or 3 months after delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- Survey
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2018to 8 Dec 2020
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Primiparous women, delivery at hospital.
Who may be able to join
- Primiparous woman
- Age between 18 and 45 years old
- Delivery after 37 weeks of amenorrhea
- Speaking French
- Pregnancy, delivery and new-born examination without morphologic or biometric abnormalities, respiratory distress and no pathology discovered at neonatal screening on day 3
- Heterosexual woman with partner
- Signed consent
- Affiliate of national health insurance scheme
Who cannot join
- Multiple pregnancy,
- BMI > 30
- Conjugopathie
- Known psychiatric history
- Medical history with gynecologic impact
- Surgery history with gynecologic impacts
- Hysterectomy post-delivery
- Protected by French law
Trial locations and contacts
1 site in 1 country.
About this study
Study of management of pain and information given to women post-delivery and their impact of the resumption of sexuality.
Survey to be completed by women at 8 and 15 days and 1 or 3 months after delivery.
- Being tested
- Survey
- Medical subject headings
- Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey completed at 1 day, 8 days 1 or 3 months post delivery
| Study group | Role | What they receive |
|---|---|---|
| Women post-delivery | Not described Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-delivery sexuality resumption
Time to sexuality resumption
Measured: 3 months
Secondary outcomes (3)
Discussion with healthcare professional on post-delivery sexuality
Number of women receiving advice from a health professional
Measured: 1 month
Pain post-delivery
Number of women needed pain treatment or with problem for sexuality resumption
Measured: 3 months
Sexual health
Frequency of sex
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start22 Dec 2018
- Primary completion8 Dec 2020
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SexualityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953573
- Sponsor's protocol ID
- 2018_0057
- Acronym
- SMD
- Status last verified
- Mar 2021
- First submitted
- 15 May 2019
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Post-delivery Pain and Its Impact on Resumption of Sexuality
- ClinicalTrials.gov ID
- NCT03953573
- Acronym / sponsor ID
- SMD / 2018_0057
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 22 Dec 2018 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 16 May 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.
Study of management of pain and information given to women post-delivery and their impact of the resumption of sexuality.
Survey to be completed by women at 8 and 15 days and 1 or 3 months after delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women post-delivery | – | Other: Survey |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Primiparous women, delivery at hospital.
Key inclusion criteria (8 listed)
- Primiparous woman
- Age between 18 and 45 years old
- Delivery after 37 weeks of amenorrhea
- Speaking French
- Pregnancy, delivery and new-born examination without morphologic or biometric abnormalities, respiratory distress and no pathology discovered at neonatal screening on day 3
Key exclusion criteria (8 listed)
- Multiple pregnancy,
- BMI > 30
- Conjugopathie
- Known psychiatric history
- Medical history with gynecologic impact
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 |
|---|---|---|
| SurveySurvey completed at 1 day, 8 days 1 or 3 months post delivery | Other | Women post-delivery |
Primary outcome
Post-delivery sexuality resumption
Time frame: 3 months
Time to sexuality resumption
3 secondary outcomes
Discussion with healthcare professional on post-delivery sexuality
Time frame: 1 month
Pain post-delivery
Time frame: 3 months
Sexual health
Time frame: 3 months
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 16 Mar 2021.
- Individual participant dataSharing planned: No
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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?
An observational study of Sexuality and Delivery, run by Hopital Foch at 1 site in France.
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 8 inclusion and 8 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 16 Mar 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 France. 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?
Post-delivery sexuality resumption (time frame: 3 months). 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 16 Mar 2021.