EpilepsyWEPODNCT01259310
Women With Epilepsy: Pregnancy Outcomes and Deliveries
An observational study of Epilepsy, run by NYU Langone Health at 3 sites in United States.
Trial summary
This is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE). 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
- Epilepsy
- How many people
- 199 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to Mar 2015
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with epilepsy between 18 and 40 years of age, recruited from epilepsy clinics in New York and Boston, and control women without epilepsy between 18 and 40 years of age, recruited from Obstetrics and Gynaecology clinics, local academic institutions, and referrals from epilepsy clinic employees or patients.
Who may be able to join
- between ages 18 and 40
- planning pregnancy
- stopped birth control or planning to stop birth control
- for women with epilepsy: receiving at least one AED (lamotrigine, levetiracetam, carbamazepine, phenytoin, oxcarbazepine, phenobarbital, topiramate, rufinamide). If on polytherapy, AEDs cannot include lamotrigine, levetiracetam or valproate.
Who cannot join
- Use of hormonal therapies for contraception
- demonstrated infertility with the same partner (more than 12 months of unprotected intercourse without achieving pregnancy)
- diagnosis of infertility
- Polycystic ovarian syndrome
- severe endometriosis
- currently breastfeeding
Show all 12Show fewer
- male factor infertility
- surgical or medical menopause
- smokers who have more than 10 cigarettes per day
- untreated thyroid disease
- hyperprolactinemia or other pituitary disease
- recently trying to achieve pregnancy for more than 6 months with having regular vaginal sexual intercourse without contraception
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
North Shore Long Island Jewish Health System
Great Neck, New York, 11021
NYU Langone Medical Center
New York, New York, 10016
About this study
This is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE).
Read the detailed description
This is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE). The investigators will determine if pregnancy rates differ in WWE compared to WWoE. Covariates of interest include proportion of ovulatory cycles, sexual activity, and type of anti-epileptic drug (AED). The investigators will compare seizure frequency during preconception to seizure frequency during pregnancy, with analysis of covariates of interest (AED type, AED ratio-to-target concentrations, and epilepsy syndrome). The investigators will also observe interactions between seizures/epilepsy, AEDs, and sex steroid hormones during this opportune time when women are not on birth control. Patterns of seizures will be evaluated for accepted catamenial patterns with consideration of ovulatory and anovulatory cycles, AED concentrations, and epilepsy type.
- Conditions
- Epilepsy
- Keywords
- fertility, women, epilepsy, pregnancy, seizures, seizure frequency, ovulation, menstruation, hormones, progesterone
- Medical subject headings
- Epilepsy, Seizures
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 |
|---|---|---|
| Women with epilepsy | Women with epilepsy, age 18-40 years, who express a desire to conceive and have stopped or plan to stop taking birth control. | |
| Women without epilepsy | Healthy women, age 18-40 years, who express a desire to conceive and have stopped or plan to stop taking birth control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility in women with epilepsy compared to healthy controls
Percentage of women who have a live birth within the time frame.
Measured: 1.75 years
Secondary outcomes (1)
Seizure frequency in women with epilepsy at baseline compared to during pregnancy
Measured: 1.75 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Northwell Health
- Responsible party
- Sponsor
- Investigators
- Jacqueline French, MD, Principal investigator, NYU School of MedicinePage Pennell, MD, Principal investigator, Brigham and Women's HospitalCynthia Harden, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259310
- Sponsor's protocol ID
- WEPOD
- Acronym
- WEPOD
- Status last verified
- Mar 2016
- First submitted
- 10 Dec 2010
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women With Epilepsy: Pregnancy Outcomes and Deliveries
- ClinicalTrials.gov ID
- NCT01259310
- Acronym / sponsor ID
- WEPOD / WEPOD
- Conditions
- Epilepsy
- Keywords
- fertility, women, epilepsy, pregnancy, seizures, seizure frequency, ovulation, menstruation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Northwell Health
- Study start
- Nov 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 Dec 2010 (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.
This is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE).
Detailed description
This is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE). The investigators will determine if pregnancy rates differ in WWE compared to WWoE. Covariates of interest include proportion of ovulatory cycles, sexual activity, and type of anti-epileptic drug (AED). The investigators will compare seizure frequency during preconception to seizure frequency during pregnancy, with analysis of covariates of interest (AED type, AED ratio-to-target concentrations, and epilepsy syndrome). The investigators will also observe interactions between seizures/epilepsy, AEDs, and sex steroid hormones during this opportune time when women are not on birth control. Patterns of seizures will be evaluated for accepted catamenial patterns with consideration of ovulatory and anovulatory cycles, AED concentrations, and epilepsy type.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with epilepsy | – | –Women with epilepsy, age 18-40 years, who express a desire to conceive and have stopped or plan to stop taking birth control. |
| Women without epilepsy | – | –Healthy women, age 18-40 years, who express a desire to conceive and have stopped or plan to stop taking birth control. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with epilepsy between 18 and 40 years of age, recruited from epilepsy clinics in New York and Boston, and control women without epilepsy between 18 and 40 years of age, recruited from Obstetrics and Gynaecology clinics, local academic institutions, and referrals from epilepsy clinic employees or patients.
Key inclusion criteria (4 listed)
- between ages 18 and 40
- planning pregnancy
- stopped birth control or planning to stop birth control
- for women with epilepsy: receiving at least one AED (lamotrigine, levetiracetam, carbamazepine, phenytoin, oxcarbazepine, phenobarbital, topiramate, rufinamide). If on polytherapy, AEDs cannot include lamotrigine, levetiracetam or valproate.
Key exclusion criteria (12 listed)
- Use of hormonal therapies for contraception
- demonstrated infertility with the same partner (more than 12 months of unprotected intercourse without achieving pregnancy)
- diagnosis of infertility
- Polycystic ovarian syndrome
- severe endometriosis
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
Fertility in women with epilepsy compared to healthy controls
Time frame: 1.75 years
Percentage of women who have a live birth within the time frame.
1 secondary outcome
Seizure frequency in women with epilepsy at baseline compared to during pregnancy
Time frame: 1.75 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 7 Mar 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.
Jacqueline French, MD principal investigator
NYU School of Medicine
Page Pennell, MD principal investigator
Brigham and Women's Hospital
Cynthia Harden, MD principal investigator
Northwell Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by NYU Langone Health at 3 sites in United States.
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 12 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 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Fertility in women with epilepsy compared to healthy controls (time frame: 1.75 years). 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 7 Mar 2016.