MAYFLOWERS: Prospective Study of Pregnancy in Women With Cystic Fibrosis

Sponsor

Amalia Magaret (Other)

Overall Status

Recruiting

CT.gov ID

NCT04828382

Collaborator

University of Texas (Other), National Jewish Health (Other), Cystic Fibrosis Foundation (Other)

285

Enrollment

Locations

Anticipated Duration (Months)

7.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, the investigators aim to evaluate changes in lung function in women with cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related Cystic Fibrosis

Detailed Description

Advances in medical treatment, including the use of highly effective CFTR modulators have greatly increased life expectancy in women with CF, but the effects of pregnancy on women with CF are yet unknown. It is anticipated that over 90% of the CF population will be on CFTR modulators in the next few years. More knowledge about the effects of CFTR modulators in pregnancy is needed.

This is a prospective, multi-center, observational study to follow pregnant women with CF, conducted at 40 US sites. Women are enrolled in the first trimester of pregnancy and assessed every 3 months during pregnancy and during the first year after delivery, then every 6 months for an additional year. Changes in lung function over the course of pregnancy will be evaluated based on cumulative CFTR modulator use while pregnant while accounting for other factors that may influence changes in pulmonary function: baseline lung function, genotype, history of exacerbations, and pre-existing co-morbid conditions.

Study Design

Study Type:

Observational

Anticipated Enrollment :

285 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective Study Evaluating Maternal and Fetal Outcomes in the Era of Modulators

Actual Study Start Date :

Sep 30, 2021

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Outcome Measures

Primary Outcome Measures

Forced expiratory volume at one second (FEV1) percent predicted after delivery and restart of modulators [42 weeks]
Change in FEV1 percent predicted after delivery and restart of modulators relative to measures assessed prior to pregnancy
Forced expiratory volume at one second (FEV1) percent predicted after delivery [42 weeks]
Change in FEV1 percent predicted after delivery relative to measures assessed prior to pregnancy

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Pregnant, intending to continue pregnancy, enrolled in the CFF registry

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	University of California San Diego	La Jolla	California	United States	92093
4	Center for Cystic Fibrosis at Keck Medical Center of USC	Los Angeles	California	United States	90033
5	National Jewish Health	Denver	Colorado	United States	80206
6	University of Florida	Gainesville	Florida	United States	32610
7	Joe DiMaggio Children's Hospital	Hollywood	Florida	United States	33021
8	Emory University	Atlanta	Georgia	United States	30327
9	Saint Luke's Cystic Fibrosis Center of Idaho	Boise	Idaho	United States	83702
10	Indiana University Medical Center	Indianapolis	Indiana	United States	46202
11	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
12	University of Kentucky	Lexington	Kentucky	United States	40536
13	Tulane University	New Orleans	Louisiana	United States	70112
14	John Hopkins Hospital	Baltimore	Maryland	United States	21205
15	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
16	Boston Children's Hospital, Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
17	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
18	Helen DeVos Children's Hospital	Grand Rapids	Michigan	United States	49546
19	The Minnesota Cystic Fibrosis Center	Minneapolis	Minnesota	United States	55455
20	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
21	University of Nebraska Medical Center	Omaha	Nebraska	United States	69198
22	The Cystic Fibrosis Center of Western New York	Buffalo	New York	United States	14203
23	Columbia University Cystic Fibrosis Program	New York	New York	United States	10032
24	SUNY Upstate Medical University	Syracuse	New York	United States	13210
25	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27517
26	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45267
27	Cleveland Clinic Cystic Fibrosis Program	Cleveland	Ohio	United States	44195
28	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
29	Oregon Health Sciences University	Portland	Oregon	United States	97239
30	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
31	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15224
32	Medical University of South Carolina	Charleston	South Carolina	United States	29425
33	Vanderbilt Children's Hospital	Nashville	Tennessee	United States	37232
34	University of Texas Southwestern	Dallas	Texas	United States	75390
35	Baylor College of Medicine	Houston	Texas	United States	77030
36	Intermountain Cystic Fibrosis Center	Salt Lake City	Utah	United States	84132
37	University of Washington Medical Center	Seattle	Washington	United States	98195
38	University of Wisconsin	Madison	Wisconsin	United States	53792
39	Froedtert & Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226