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Completed

NCT Number: NCT01259310

Women With Epilepsy: Pregnancy Outcomes and Deliveries

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).

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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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). 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Seizure frequency in women with epilepsy at baseline compared to during pregnancy

    Time frame: 1.75 years

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Brigham and Women's Hospital
  • Northwell Health

Registry information

Acronym: WEPOD

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Dec 14, 2010
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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