DyspareuniaNCT01753258
Outcomes of Delivery in Patients With Dyspareunia
An observational study of Dyspareunia and Pregnancy, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The focus of this pilot study is to determine if a woman who experiences pain during sexual intercourse has a higher risk of complications during labor and delivery secondary to pelvic floor dysfunction, anxiety and intolerance towards pelvic examinations. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dyspareunia, Pregnancy, Provoked Vestibulodynia
- How many people
- 173 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Sep 2016
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Nulliparous women admitted to the Labor and Delivery Department at the Hadassah Medical Center, above the age of 18
Who may be able to join
- 200 nulliparous women admitted to the Labor and Delivery Department at the Hadassah Medical Center, above the age of 18.
- Able and willing to read, understand, and sign the Informed Consent Form and questionnaire.
- Agree to be contacted in the future to complete telephone questionnaires.
Who cannot join
- Induction of labor
- Placental abruption, placenta previa
- Malpresentation
- Non reassuring fetal heart rate upon admission
- Any other contraindication for vaginal delivery
- Multifetal pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Delivery in Patients With Dyspareunia- A Prospective Study
The focus of this pilot study is to determine if a woman who experiences pain during sexual intercourse has a higher risk of complications during labor and delivery secondary to pelvic floor dysfunction, anxiety and intolerance towards pelvic examinations. Furthermore, it is unclear whether women with prepartum dyspareunia experience an improvement following vaginal delivery. While physicians may expect that vaginal birth improves dyspareunia due to the stretching effect on pelvic floor, to date, there is insufficient evidence to support this claim. The Investigators plan to prospectively study 200 patients at our Institution, collect information regarding birth and follow them, via questionnaires, regarding their dyspareunia postpartum.
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Definite diagnosis of dyspareunia | Patients who report dyspareunia, and whose dyspareunia was evaluated prior to delivery by a caregiver experienced with sexual pain disorders, with definite diagnosis. | |
| No definite diagnosis of dyspareunia | Patients who report dyspareunia but were not evaluated prior to delivery or were evaluated inappropriately (i.e. "yeast infection" without cultures, "inflammation" and other vague definitions). | |
| Patients without dyspareunia | Patients without dyspareunia- those who report non painful sexual intercourse. This group of patients will be used as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetrical outcome of women with a history of dyspareunia
The Investigators will record the mode of delivery (vaginal, instrumental or cesarean section), length of the second stage of labor, use of anesthetics, perineal tears and\or episiotomies, and newborn's birth weight. The evaluation will be done prospectively, comparing data with matched controls without a history of dyspareunia.
Measured: 3 months -1 year
Secondary outcomes (1)
Rate of alleviation of dyspareunia following vaginal delivery as assessed through patient questionnaires.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspareuniaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahinoam Lev-Sagie, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753258
- Sponsor's protocol ID
- Delivery-Dyspareunia-HMO-CTIL
- Status last verified
- Oct 2016
- First submitted
- 12 Dec 2012
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Delivery in Patients With Dyspareunia- A Prospective Study
- ClinicalTrials.gov ID
- NCT01753258
- Acronym / sponsor ID
- Delivery-Dyspareunia-HMO-CTIL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Dec 2012 (estimated)
- 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.
The focus of this pilot study is to determine if a woman who experiences pain during sexual intercourse has a higher risk of complications during labor and delivery secondary to pelvic floor dysfunction, anxiety and intolerance towards pelvic examinations. Furthermore, it is unclear whether women with prepartum dyspareunia experience an improvement following vaginal delivery. While physicians may expect that vaginal birth improves dyspareunia due to the stretching effect on pelvic floor, to date, there is insufficient evidence to support this claim. The Investigators plan to prospectively study 200 patients at our Institution, collect information regarding birth and follow them, via questionnaires, regarding their dyspareunia postpartum.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Definite diagnosis of dyspareunia | – | –Patients who report dyspareunia, and whose dyspareunia was evaluated prior to delivery by a caregiver experienced with sexual pain disorders, with definite diagnosis. |
| No definite diagnosis of dyspareunia | – | –Patients who report dyspareunia but were not evaluated prior to delivery or were evaluated inappropriately (i.e. "yeast infection" without cultures, "inflammation" and other vague definitions). |
| Patients without dyspareunia | – | –Patients without dyspareunia- those who report non painful sexual intercourse. This group of patients will be used as a control group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Nulliparous women admitted to the Labor and Delivery Department at the Hadassah Medical Center, above the age of 18
Key inclusion criteria (3 listed)
- 200 nulliparous women admitted to the Labor and Delivery Department at the Hadassah Medical Center, above the age of 18.
- Able and willing to read, understand, and sign the Informed Consent Form and questionnaire.
- Agree to be contacted in the future to complete telephone questionnaires.
Key exclusion criteria (6 listed)
- Induction of labor
- Placental abruption, placenta previa
- Malpresentation
- Non reassuring fetal heart rate upon admission
- Any other contraindication for vaginal delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Obstetrical outcome of women with a history of dyspareunia
Time frame: 3 months -1 year
The Investigators will record the mode of delivery (vaginal, instrumental or cesarean section), length of the second stage of labor, use of anesthetics, perineal tears and\or episiotomies, and newborn's birth weight. The evaluation will be done prospectively, comparing data with matched controls without a history of dyspareunia.
1 secondary outcome
Rate of alleviation of dyspareunia following vaginal delivery as assessed through patient questionnaires.
Time frame: 2 years
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 11 Oct 2016.
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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.
Ahinoam Lev-Sagie, MD principal investigator
Hadassah Medical Organization
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 Dyspareunia and Pregnancy, run by Hadassah Medical Organization at 1 site in Israel.
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 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 11 Oct 2016. 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 Israel. 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?
Obstetrical outcome of women with a history of dyspareunia (time frame: 3 months -1 year). 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 11 Oct 2016.