Women With Epilepsy: Pregnancy Outcomes and Deliveries

NCT01259310 | Completed

• 1 other identifier: WEPOD
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Epilepsy

Keywords

fertility; women; epilepsy; pregnancy; seizures; seizure frequency; ovulation; menstruation; hormones; progesterone

Outcome Measures

Primary Outcomes (1)

• Fertility in women with epilepsy compared to healthy controls

  Percentage of women who have a live birth within the time frame.

  1.75 years

Secondary Outcomes (1)

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

  1.75 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Brigham and Women's Hospital: collaborator
• Northwell Health: collaborator

Study Sites (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

North Shore Long Island Jewish Health System

Great Neck, New York, 11021, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacqueline French, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

• Page Pennell, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Cynthia Harden, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 14, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 7, 2016

Record last verified: 2016-03

Locations

US (3)