Helping Women with Rheumatic Disease Have Families

Tuesday, April 9, 2019

In her clinic, Megan Clowse, MD, MPH, associate professor of medicine (Rheumatology and Immunology), helps patients with rheumatic disease safely navigate pregnancy while managing their disease. In her research, she gathers and analyzes data about the best pregnancy planning and management practices. She’s also working to educate providers and patients on a larger scale.

“I’m trying to figure out how everyone can get state-of-the-art care from their local rheumatologist in order to have healthy pregnancies,” she says. “My mission is that all women with rheumatic disease can have the families they want.”

It used to be that women with certain forms of rheumatic disease — like lupus — were told it wasn’t safe to get pregnant. If they did get pregnant, most doctors advised them to stop taking maintenance medications and to treat any resulting flare-ups of the disease with prednisone.

“Over the last 20 years, a lot of data has been collected that shows that that is not the best way to have a safe pregnancy for the mother or infant,” says Dr. Clowse. Instead, it’s safer to stay on pregnancy-compatible medications throughout pregnancy to keep the disease in remission and to reduce the need for prednisone.

In 2007, Clowse started the Duke Autoimmunity in Pregnancy (DAP) Registry to collect data about disease activity and pregnancy outcomes in pregnant women with rheumatoid disease. Over the next decade, 425 pregnant women participated. About a third of them had lupus, a third had various types of inflammatory arthritis, and a third had other conditions including undifferentiated connective tissue disease (UCTD) and Sjogren’s syndrome.

Women with UCTD had the best pregnancy outcomes, with rates of complication similar to those of the general public. Women with inflammatory arthritis also had good outcomes, with very low rates of pregnancy loss. However, women with lupus had two to three times the rate of pregnancy loss, preterm birth, and preeclampsia, and their babies were two to three times as likely to be small for gestational age or to require a stay in the NICU. Among those with lupus, those who stuck to their maintenance medications throughout pregnancy had better outcomes. 

In 2018, Clowse expanded DAP to include data from patients at other institutions. To reflect the broader scope, the database is now known as the Maternal Autoimmune Disease Research Alliance (MADRA). With more patient data, Clowse hopes the database will spur even more research. Learn more about DAP.

Lisa Sammaritano, MD, a rheumatologist at Hospital for Special Surgery in New York, will soon be joining MADRA as a co-investigator. “Megan is a leader in the field of reproductive medicine in rheumatology patients,” Dr. Sammaritano says. “She not only conducts her clinical research in improving outcomes but also devotes time and effort to the critical issue of physician and patient education.”

One of the driving forces behind Clowse’s work is her own experience of pregnancy and motherhood. “I had very challenging pregnancies, and I think that has contributed to my interest in pregnancy and my desire to help women through challenging times,” she says.

She was on bed rest for four months with her daughter, who was born early but healthy. With her son, pregnancy was a breeze, but as soon as he was born he began turning blue. He spent nine weeks in the NICU, eight of them intubated, due to large pleural effusions of unknown origin. Although he almost didn’t pull through, his lungs are now perfectly healthy.

Her children are now 14 and 10. “I see the value and the importance of motherhood in my life,” she says, “and it really helps me see what a loss that could be to people who are not given the opportunity to become a mother.”

The HOP-STEP Education Program

As part of her mission to turn research results into improved care, Clowse has embarked on an ambitious program called HOP-STEP, which stands for Healthy Outcomes in Pregnancy with SLE Through Education of Providers (SLE is systemic lupus erythematosus, or lupus for short). Through HOP-STEP, which is funded by a grant from GlaxoSmithKline, Clowse aims to educate both doctors and patients about pregnancy planning and management.

“Well-planned and well-managed lupus pregnancies tend to go quite well,” Clowse says, “but in unplanned lupus pregnancies or mismanaged lupus pregnancies, we see a lot of pregnancy loss or extreme prematurity or lifelong consequences for mother and baby.”

In addition to educating doctors and mothers-to-be, Clowse wants to get the two groups talking to each other. Pre-pregnancy planning leads to a smoother pregnancy, but women are sometimes hesitant to tell their rheumatologists they hope to start a family. “We heard from some doctors anger and disbelief and betrayal that women would want to have babies,” Clowse says, “but when we talked to patients it became clear that they are just women like any other women and living with lupus is not a game changer for them — it’s just one more hurdle.”

The HOP-STEP website ( features short videos in which mothers with lupus share their experiences with fertility, pregnancy, and motherhood, and offer tips for communicating with doctors. The videos are intended to support women with lupus, as well as to share the patient perspective with rheumatologists. In one video, a mother named Heather explains, “For me, it probably wasn’t a question of ‘Can I have a child?’ It was ‘OK, I want to have a child and we plan on starting so what do I need to do to get me to that point?’”

The website also has a comprehensive checklist that outlines steps for healthy pregnancies in lupus patients. Continuing medical education videos for physicians will be added to the website soon.

The HOP-STEP program also includes workshops for rheumatologists at professional meetings such as the Association of Women in Rheumatology (AWIR), and Facebook Live sessions for patients on topics such as planning for pregnancy, patient-provider communication, and which medicines are safe to take during pregnancy.

American College of Rheumatology Guidelines

In another education effort, Clowse has been working through the American College of Rheumatology (ACR) to develop guidelines for the management of rheumatoid disease in the context of pregnancy, lactation, contraception, fertility, and menopause. As a member of the Core Leadership Team, she helped complete an exhaustive literature review, develop draft guidelines, and write the manuscript. Amanda Eudy, PhD, assistant professor of medicine (Rheumatology and Immunology), contributed heavily to the literature review.

The guidelines were presented at the annual ACR meeting in the fall of 2018 and will be published in 2019. Clowse will lead the ACR steering committee charged with implementing the guidelines nationwide.

Clowse believes the ACR guidelines will not only educate doctors, but also provide authority and support. For example, for women with lupus, the data shows it’s safer to continue taking hydroxychloroquine (HCQ) during pregnancy than to risk flares.

“I’ve been harping on that for a decade and, for the most part, rheumatologists get it,” Clowse says. “But whether they can negotiate through explaining it to a patient, having the local obstetrician agree, and getting the patient to put the pills in her mouth. . . that’s not always happening.”

Clowse hopes the ACR guidelines will help everyone on the team — rheumatologist, obstetrician, and patient — stick to the same game plan, creating the best chances for a healthy mother and baby.

Learn more

Rheumatic Diseases and Pregnancy: How do Outcomes Correlate to Patient-Reported Measures?

New Lupus Subtyping System Improves Care and Communication

Rheumatic Diseases and Pregnancy: Should HCQ Dose Change in Pregnancy?

This story was written by Mary-Russell Roberson, a freelance writer for the Department of Medicine.