Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous EpisodenuMoM2b-HHSNCT02231398
nuMoM2b Heart Health Study
An observational study of Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode and Breathing-Related Sleep Disorder, run by RTI International at 15 sites in United States.
Trial summary
This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 3½ years later. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnancy in another study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode, Breathing-Related Sleep Disorder
- How many people
- 4,509 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2014to 30 Oct 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Eligible women are recruited from the cohort enrolled to nuMoM2b. For nuMom2b a convenience sample was recruited through 8 primary clinical sites that NIH selected because they could each demonstrate access to more than 4,500 deliveries per year. As a group, sites were geographically dispersed and ethically diverse. All nulliparous women aged 13 years or greater with a singleton pregnancy less than 13 weeks 6 days gestation who presented at recruitment clinics or practices and planned to deliver at a study hospital were potentially eligible for participation. A clinical or research ultrasound, performed by a study certified sonographer, confirmed viability of a singleton gestation with no obvious malformations and estimated gestational age less than or equal to 13 weeks 6 days before the woman was allowed enrollment. The first visit was scheduled and completed within a window of 6 weeks 0 days and 13 weeks 6 days estimated gestational age.
Who may be able to join
- Interval Contact:
- Agreed to contact for future studies during nuMoM2b and not subsequently withdrawn from the cohort.
- Have pregnancy outcome data from the nuMoM2b study.
- At least 18 years of age (to begin interval contact attempts once nuMoM2b participant reaches age 18).
- Provision of verbal consent for telephone interview or acknowledgement of consent with completion of the web-based self-administered questionnaire.
- In-clinic Visit:
Show all 21Show fewer
- Consented for participation in interval contacts and not subsequently withdrawn
- Between 2 and 3.5 years after the nuMoM2b pregnancy ended
- Self-report at least 6 months postpartum from any subsequent pregnancy
- Self-report not currently pregnant
- Able to provide informed consent
- Provision of written, signed, informed consent for the 2 to 3.5 year in-clinic assessment
- Not currently pregnant by urine pregnancy test administered in the clinic following consent
- In-home Sleep Breathing Assessment after the In-Clinic Visit:
- Participation in the in-clinic visit
- Participation in the sleep breathing substudy of nuMoM2b with at least one sleep breathing assessment providing valid data
- Not currently using positive airway pressure (PAP) therapy or other approved treatments for sleep apnea such as oral appliances and nasal therapy patch (Provent)
- Not currently on continuous oral steroid therapy for 14 days or more to treat asthma
- Not currently using oxygen supplementation to treat a medical condition
- Able to provide informed consent and deemed likely to return equipment in a reasonable period
- Provision of written, signed, informed consent for the sleep breathing assessment for the nuMoM2b Heart Health Study
Who cannot join
- Inability or refusal to provide informed consent for the study component.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Northwestern University
Chicago, Illinois, 60611
Case Western Reserve University, MetroHealth Medical Center
Cleveland, Ohio, 44109
Fountain Valley Regional Hospital and Medical Center- UCI MFM private practice
Fountain Valley, California, 92708
Indiana University School of Medicine OB/GYN
Indianapolis, Indiana, 46202
Long Beach Memorial Medical Center, Women's and Children's Hospital - Women's Perinatal Group, OB Clinic
Long Beach, California, 90801
Columbia University Medical Center- Department of OB/GYN Division of Maternal Fetal Medicine
New York, New York, 10032
Christiana Care Health Systems
Newark, Delaware, 19718
McKay Dee Hospital
Ogden, Utah, 84403
University of California, Irvine, Medical Center - Prenatal care clinics and private practice
Orange, California, 92868
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Utah Valley Regional Medical Center
Provo, Utah, 84604
University of Utah
Salt Lake City, Utah, 84106
Intermountain Medical Center
Salt Lake City, Utah, 84107
LDS Hospital
Salt Lake City, Utah, 84143
About this study
Official title: Pregnancy as a Window to Future Cardiovascular Health: Adverse Pregnancy Outcomes as Predictors of Increased Risk Factors for Cardiovascular Disease
This study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 3½ years later. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnancy in another study.
Read the detailed description
The National Heart, Lung, and Blood Institute (NHLBI), in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, is funding this follow-up study of the nuMoM2b cohort to evaluate the association between adverse pregnancy outcomes (APOs) and cardiovascular health approximately 2 to 3½ years postpartum. The study, called the nuMoM2b Heart Health Study or nuMoM2b HHS, utilizes the extensive database and tissue bank developed for nuMoM2b in which nulliparous women are evaluated over the course of pregnancy to study the mechanisms for and prediction of APOs. Women enrolled in the nuMoM2b cohort are extremely well phenotyped through prospective data collection, clinical evaluations, and ultrasound assessments, as well as through the use of standardized definitions. Demographic, psychosocial, dietary, physiologic, and outcome information were collected through maternal interviews, self-administered questionnaires, clinical measurements, ultrasounds, and medical record abstraction. Samples of maternal blood, urine, and cervico-vaginal fluid over pregnancy and cord blood and placenta at delivery were collected and banked. All women completed two sleep questionnaires and over 3,600 had objective overnight sleep studies at two times during pregnancy.
Women participating in the nuMoM2b are assessed in nuMoM2b HHS for evidence of cardiovascular disease risk (CVDR), including sleep disordered breathing (SDB), at 2 to 3½ years postpartum. APOs in subsequent pregnancies also are assessed. This study characterizes the relationship between APOs and CVDR, identify first pregnancy profiles that portend subsequent CVDR, determine associations between SDB during the first pregnancy and subsequent CVDR, and identify modifiable factors that mediate the associations between CVDR and APOs in the first and subsequent pregnancy. This follow-up study will allow for the development of strategies to modify these CVDR factors and to improve the health of women suffering APOs.
The nuMoM2b Heart Health Study is a prospective observational study that includes interval contacts and a detailed cardiovascular assessment 2 to 3½ years after delivery of the index pregnancy. At the cardiovascular assessment, potentially eligible women are invited to attend a cardiovascular screening visit. After informed consent, a urine pregnancy test is performed to confirm eligibility. The visit includes clinical and laboratory measurements as well as a structured interview to assess domains that were measured in the nuMoM2b pregnancy: physical activity, depression, social support, psychological stress, and nutritional status. Women with sleep breathing assessments during their nuMoM2b pregnancy are offered another overnight sleep study.
The overarching goal is to better define the relation between outcomes of pregnancy and long term health of the mother. The specific aims are as follows:
Aim 1: Define the incidence of hypertension and the cardiovascular disease risk (CVDR) profile of women approximately 2 to 3½ years after a first pregnancy complicated by preeclampsia or other adverse pregnancy outcomes (APOs: stillbirth, small for gestational age at birth [SGA], preterm birth, preeclampsia, pregnancy-associated hypertension, gestational diabetes [GDM]) compared to women having no APOs in the first pregnancy.
Aim 2: Identify a profile in early pregnancy that portends subsequent CVDR approximately 2 to 3½ years postpartum.
Aim 3: Determine whether pregnancy and postpartum sleep disordered breathing (SDB) is associated with increased CVDR and identify specific patterns of pregnancy and postpartum SDB that increase CVDR.
Aim 4: Identify modifiable factors during and after pregnancy that mediate the associations between APOs and the CVDR during pregnancy and approximately 2 to 3½ years postpartum.
- Conditions
- Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode, Breathing-Related Sleep Disorder
- Keywords
- Cardiovascular disease, Pregnant women, Nulliparity, Pregnancy outcomes, Pregnancy complications, Sleep disordered breathing
- Medical subject headings
- Cardiovascular Diseases, Pregnancy Complications, Sleep Apnea Syndromes
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 who participated in nuMoM2b | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension, defined as systolic blood pressure above 140 mm Hg or diastolic blood pressure above 90 mm Hg
Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
Measured: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum
Secondary outcomes (9)
Systolic blood pressure in mm Hg
Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
Measured: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum
Diastolic blood pressures in mm Hg
Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
Measured: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum
HDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours
Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
Measured: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
LDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours
Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
Measured: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
Triglycerides in mg/dL from blood sample following overnight fast of at least 8 hours
Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
Measured: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from glucose and insulin measured from blood sample following overnight fast of at least 8 hours
Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
Measured: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
High sensitivity C-reactive protein (hs-CRP) in mg/L measured from blood sample following overnight fast of at least 8 hours
Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
Measured: Taken at study clinic visit between 2 and 3.5 years postpartum
Hemoglobin A1c (%) measured from blood sample following overnight fast of at least 8 hours
Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
Measured: Taken at study clinic visit between 2 and 3.5 years postpartum
Sleep disordered breathing, defined as apnea-hypopnea index (AHI) of 3 or more
AHI calculated for apnea-hypopnea events with 3% desaturation.
Measured: Taken at study clinic visit between 2 and 3.5 years postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion30 Oct 2017
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous EpisodeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,509 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Becky McNeil, RTI International
- Investigators
- George Saade, M.D., Study chair, The University of Texas Medical Branch, GalvestonBrian M. Mercer, MD, Principal investigator, Case Western Reserve UniversityRonald Wapner, MD, Principal investigator, Columbia UniversityDavid M. Haas, M.D., M.S.,, Principal investigator, Indiana UniversityHyagriv N. Simhan, MD, MSCR, Principal investigator, Magee Womens Hospital - University of PittsburghWilliam Grobman, M.D., M.B.A., Principal investigator, Northwestern UniversityJudith Chung, M.D., Principal investigator, University CA IrvineSamuel Parry, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231398
- Sponsor's protocol ID
- NHLBI-nuMoM2b-HHS-001
- Other IDs
- 1U10HL119991
- Acronym
- nuMoM2b-HHS
- Status last verified
- Jan 2022
- First submitted
- 28 Aug 2014
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data will be made available through an NIH data repository.
Publications
Haas DM, Ehrenthal DB, Koch MA, Catov JM, Barnes SE, Facco F, Parker CB, Mercer BM, Bairey-Merz CN, Silver RM, Wapner RJ, Simhan HN, Hoffman MK, Grobman WA, Greenland P, Wing DA, Saade GR, Parry S, Zee PC, Reddy UM, Pemberton VL, Burwen DR; National Heart, Lung, and Blood Institute nuMoM2b Heart Health Study Network. Pregnancy as a Window to Future Cardiovascular Health: Design and Implementation of the nuMoM2b Heart Health Study. Am J Epidemiol. 2016 Mar 15;183(6):519-30. doi: 10.1093/aje/kwv309. Epub 2016 Jan 28.
PubMed 26825925Catov JM, Parker CB, Gibbs BB, Bann CM, Carper B, Silver RM, Simhan HN, Parry S, Chung JH, Haas DM, Wapner RJ, Saade GR, Mercer BM, Bairey-Merz CN, Greenland P, Ehrenthal DB, Barnes SE, Shanks AL, Reddy UM, Grobman WA; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Network. Patterns of leisure-time physical activity across pregnancy and adverse pregnancy outcomes. Int J Behav Nutr Phys Act. 2018 Jul 11;15(1):68. doi: 10.1186/s12966-018-0701-5.
PubMed 29996930Facco FL, Parker CB, Hunter S, Reid KJ, Zee PC, Silver RM, Haas DM, Chung JH, Pien GW, Nhan-Chang CL, Simhan HN, Parry S, Wapner RJ, Saade GR, Mercer BM, Torres C, Knight J, Reddy UM, Grobman WA; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Networks. Association of Adverse Pregnancy Outcomes With Self-Reported Measures of Sleep Duration and Timing in Women Who Are Nulliparous. J Clin Sleep Med. 2018 Dec 15;14(12):2047-2056. doi: 10.5664/jcsm.7534.
PubMed 30518449Brubaker LH, Catov JM, Bairey Merz CN, Barnes S, Barone Gibbs B, Booker W, Chung JH, Greenland P, Grobman WA, Khan SS, Lane A, Levine LD, McNeil RB, Miller EC, Muldoon MF, Ray M, Saade GR, Scifres CM, Silver RM, Simhan H, Yee LM, Hauspurg A. Subtypes of Hypertension 2 to 7 Years After First Pregnancy. Hypertension. 2026 Aug;83(8):e26296. doi: 10.1161/HYPERTENSIONAHA.125.26296. Epub 2026 Jun 9.
PubMed 42261656Hauspurg A, Grobman W, Jancsura MK, Yee LM, Waks A, Simhan H, Levine LD, Theilen L, Greenland P, McNeil R, Bairey Merz CN, Shahrokni N, Haas D, Khan SS, Venkatesh KK, Catov J. Timing of Hypertensive Disorders of Pregnancy in Nulliparous Individuals and Risk of Incident Chronic Hypertension 2-7 Years Postpartum. Obstet Gynecol. 2026 Jul 1;148(1):e25-e32. doi: 10.1097/AOG.0000000000006191. Epub 2026 Feb 12.
PubMed 41678805Haas DM, Yang Z, Parker CB, Chung J, Parry S, Grobman WA, Mercer BM, Simhan HN, Silver RM, Wapner RJ, Saade GR, Greenland P, Merz NB, Reddy UM, Pemberton VL; nuMoM2b study and the nuMoM2b Heart Health Study. Factors associated with duration of breastfeeding in women giving birth for the first time. BMC Pregnancy Childbirth. 2022 Sep 22;22(1):722. doi: 10.1186/s12884-022-05038-7.
PubMed 36138368Facco FL, Redline S, Hunter SM, Zee PC, Grobman WA, Silver RM, Louis JM, Pien GW, Mercer B, Chung JH, Bairey Merz CN, Haas DM, Nhan-Chang CL, Simhan HN, Schubert FP, Parry S, Reddy U, Saade GR, Hoffman MK, Levine LD, Wapner RJ, Catov JM, Parker CB. Sleep-disordered Breathing in Pregnancy and after Delivery: Associations with Cardiometabolic Health. Am J Respir Crit Care Med. 2022 May 15;205(10):1202-1213. doi: 10.1164/rccm.202104-0971OC.
PubMed 35144521Hawkins M, Parker CB, Redline S, Larkin JC, Zee PP, Grobman WA, Silver RM, Louis JM, Pien GW, Basner RC, Chung JH, Haas DM, Nhan-Chang CL, Simhan HN, Blue NR, Parry S, Reddy U, Facco F; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Networks. Objectively assessed sleep-disordered breathing during pregnancy and infant birthweight. Sleep Med. 2021 May;81:312-318. doi: 10.1016/j.sleep.2021.02.043. Epub 2021 Feb 27.
PubMed 33756281Catov JM, McNeil RB, Marsh DJ, Mercer BM, Bairey Merz CN, Parker CB, Pemberton VL, Saade GR, Chen YI, Chung JH, Ehrenthal DB, Grobman WA, Haas DM, Parry S, Polito L, Reddy UM, Silver RM, Simhan HN, Wapner RJ, Kominiarek M, Kreutz R, Levine LD, Greenland P; NHLBI nuMoM2b Heart Health Study. Early Pregnancy Atherogenic Profile in a First Pregnancy and Hypertension Risk 2 to 7 Years After Delivery. J Am Heart Assoc. 2021 Feb;10(5):e017216. doi: 10.1161/JAHA.120.017216. Epub 2021 Feb 23.
PubMed 33619977Haas DM, Parker CB, Marsh DJ, Grobman WA, Ehrenthal DB, Greenland P, Bairey Merz CN, Pemberton VL, Silver RM, Barnes S, McNeil RB, Cleary K, Reddy UM, Chung JH, Parry S, Theilen LH, Blumenthal EA, Levine LD, Mercer BM, Simhan H, Polito L, Wapner RJ, Catov J, Chen I, Saade GR; NHLBI nuMoM2b Heart Health Study. Association of Adverse Pregnancy Outcomes With Hypertension 2 to 7 Years Postpartum. J Am Heart Assoc. 2019 Oct;8(19):e013092. doi: 10.1161/JAHA.119.013092. Epub 2019 Sep 30.
PubMed 31564189Monk C, Webster RS, McNeil RB, Parker CB, Catov JM, Greenland P, Bairey Merz CN, Silver RM, Simhan HN, Ehrenthal DB, Chung JH, Haas DM, Mercer BM, Parry S, Polito L, Reddy UM, Saade GR, Grobman WA; NICHD nuMoM2b and NHLBI nuMoM2b Heart Health Study Networks. Associations of perceived prenatal stress and adverse pregnancy outcomes with perceived stress years after delivery. Arch Womens Ment Health. 2020 Jun;23(3):361-369. doi: 10.1007/s00737-019-00970-8. Epub 2019 Jun 29.
PubMed 31256258
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy as a Window to Future Cardiovascular Health: Adverse Pregnancy Outcomes as Predictors of Increased Risk Factors for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT02231398
- Acronym / sponsor ID
- nuMoM2b-HHS / NHLBI-nuMoM2b-HHS-001
- Conditions
- Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode, Breathing-Related Sleep Disorder
- Keywords
- Cardiovascular disease, Pregnant women, Nulliparity, Pregnancy outcomes, Pregnancy complications, Sleep disordered breathing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,509 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2014
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 4 Sep 2014 (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 study is looking at the relationship between experiences during pregnancy and cardiovascular health 2 to 3½ years later. The investigators are recruiting women from the approximately 10,000 women who were enrolled and followed over the course of their first pregnancy in another study.
Detailed description
The National Heart, Lung, and Blood Institute (NHLBI), in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, is funding this follow-up study of the nuMoM2b cohort to evaluate the association between adverse pregnancy outcomes (APOs) and cardiovascular health approximately 2 to 3½ years postpartum. The study, called the nuMoM2b Heart Health Study or nuMoM2b HHS, utilizes the extensive database and tissue bank developed for nuMoM2b in which nulliparous women are evaluated over the course of pregnancy to study the mechanisms for and prediction of APOs. Women enrolled in the nuMoM2b cohort are extremely well phenotyped through prospective data collection, clinical evaluations, and ultrasound assessments, as well as through the use of standardized definitions. Demographic, psychosocial, dietary, physiologic, and outcome information were collected through maternal interviews, self-administered questionnaires, clinical measurements, ultrasounds, and medical record abstraction. Samples of maternal blood, urine, and cervico-vaginal fluid over pregnancy and cord blood and placenta at delivery were collected and banked. All women completed two sleep questionnaires and over 3,600 had objective overnight sleep studies at two times during pregnancy.
Women participating in the nuMoM2b are assessed in nuMoM2b HHS for evidence of cardiovascular disease risk (CVDR), including sleep disordered breathing (SDB), at 2 to 3½ years postpartum. APOs in subsequent pregnancies also are assessed. This study characterizes the relationship between APOs and CVDR, identify first pregnancy profiles that portend subsequent CVDR, determine associations between SDB during the first pregnancy and subsequent CVDR, and identify modifiable factors that mediate the associations between CVDR and APOs in the first and subsequent pregnancy. This follow-up study will allow for the development of strategies to modify these CVDR factors and to improve the health of women suffering APOs.
The nuMoM2b Heart Health Study is a prospective observational study that includes interval contacts and a detailed cardiovascular assessment 2 to 3½ years after delivery of the index pregnancy. At the cardiovascular assessment, potentially eligible women are invited to attend a cardiovascular screening visit. After informed consent, a urine pregnancy test is performed to confirm eligibility. The visit includes clinical and laboratory measurements as well as a structured interview to assess domains that were measured in the nuMoM2b pregnancy: physical activity, depression, social support, psychological stress, and nutritional status. Women with sleep breathing assessments during their nuMoM2b pregnancy are offered another overnight sleep study.
The overarching goal is to better define the relation between outcomes of pregnancy and long term health of the mother. The specific aims are as follows:
Aim 1: Define the incidence of hypertension and the cardiovascular disease risk (CVDR) profile of women approximately 2 to 3½ years after a first pregnancy complicated by preeclampsia or other adverse pregnancy outcomes (APOs: stillbirth, small for gestational age at birth [SGA], preterm birth, preeclampsia, pregnancy-associated hypertension, gestational diabetes [GDM]) compared to women having no APOs in the first pregnancy.
Aim 2: Identify a profile in early pregnancy that portends subsequent CVDR approximately 2 to 3½ years postpartum.
Aim 3: Determine whether pregnancy and postpartum sleep disordered breathing (SDB) is associated with increased CVDR and identify specific patterns of pregnancy and postpartum SDB that increase CVDR.
Aim 4: Identify modifiable factors during and after pregnancy that mediate the associations between APOs and the CVDR during pregnancy and approximately 2 to 3½ years postpartum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women who participated in nuMoM2b | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible women are recruited from the cohort enrolled to nuMoM2b. For nuMom2b a convenience sample was recruited through 8 primary clinical sites that NIH selected because they could each demonstrate access to more than 4,500 deliveries per year. As a group, sites were geographically dispersed and ethically diverse. All nulliparous women aged 13 years or greater with a singleton pregnancy less than 13 weeks 6 days gestation who presented at recruitment clinics or practices and planned to deliver at a study hospital were potentially eligible for participation. A clinical or research ultrasound, performed by a study certified sonographer, confirmed viability of a singleton gestation with no obvious malformations and estimated gestational age less than or equal to 13 weeks 6 days before the woman was allowed enrollment. The first visit was scheduled and completed within a window of 6 weeks 0 days and 13 weeks 6 days estimated gestational age.
Key inclusion criteria (21 listed)
- Agreed to contact for future studies during nuMoM2b and not subsequently withdrawn from the cohort.
- Have pregnancy outcome data from the nuMoM2b study.
- At least 18 years of age (to begin interval contact attempts once nuMoM2b participant reaches age 18).
- Provision of verbal consent for telephone interview or acknowledgement of consent with completion of the web-based self-administered questionnaire.
- Consented for participation in interval contacts and not subsequently withdrawn
Key exclusion criteria (1 listed)
- Inability or refusal to provide informed consent for the study component.
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
Hypertension, defined as systolic blood pressure above 140 mm Hg or diastolic blood pressure above 90 mm Hg
Time frame: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum
Will exclude participants with chronic hypertension or pregestational diabetes during or just prior to the index pregnancy.
9 secondary outcomes
Systolic blood pressure in mm Hg
Time frame: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum
Diastolic blood pressures in mm Hg
Time frame: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum
HDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours
Time frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
LDL cholesterol in mg/dL from blood sample following overnight fast of at least 8 hours
Time frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
Triglycerides in mg/dL from blood sample following overnight fast of at least 8 hours
Time frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from glucose and insulin measured from blood sample following overnight fast of at least 8 hours
Time frame: Blood sample taken at study clinic visit between 2 and 3.5 years postpartum
High sensitivity C-reactive protein (hs-CRP) in mg/L measured from blood sample following overnight fast of at least 8 hours
Time frame: Taken at study clinic visit between 2 and 3.5 years postpartum
Hemoglobin A1c (%) measured from blood sample following overnight fast of at least 8 hours
Time frame: Taken at study clinic visit between 2 and 3.5 years postpartum
Sleep disordered breathing, defined as apnea-hypopnea index (AHI) of 3 or more
Time frame: Taken at study clinic visit between 2 and 3.5 years postpartum
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 16 Feb 2022.
- Background: PubMed 26825925Haas DM, Ehrenthal DB, Koch MA, Catov JM, Barnes SE, Facco F, Parker CB, Mercer BM, Bairey-Merz CN, Silver RM, Wapner RJ, Simhan HN, Hoffman MK, Grobman WA, Greenland P, Wing DA, Saade GR, Parry S, Zee PC, Reddy UM, Pemberton VL, Burwen DR; National Heart, Lung, and Blood Institute nuMoM2b Heart Health Study Network. Pregnancy as a Window to Future Cardiovascular Health: Design and Implementation of the nuMoM2b Heart Health Study. Am J Epidemiol. 2016 Mar 15;183(6):519-30. doi: 10.1093/aje/kwv309. Epub 2016 Jan 28.
- Background: PubMed 29996930Catov JM, Parker CB, Gibbs BB, Bann CM, Carper B, Silver RM, Simhan HN, Parry S, Chung JH, Haas DM, Wapner RJ, Saade GR, Mercer BM, Bairey-Merz CN, Greenland P, Ehrenthal DB, Barnes SE, Shanks AL, Reddy UM, Grobman WA; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Network. Patterns of leisure-time physical activity across pregnancy and adverse pregnancy outcomes. Int J Behav Nutr Phys Act. 2018 Jul 11;15(1):68. doi: 10.1186/s12966-018-0701-5.
- Background: PubMed 30518449Facco FL, Parker CB, Hunter S, Reid KJ, Zee PC, Silver RM, Haas DM, Chung JH, Pien GW, Nhan-Chang CL, Simhan HN, Parry S, Wapner RJ, Saade GR, Mercer BM, Torres C, Knight J, Reddy UM, Grobman WA; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Networks. Association of Adverse Pregnancy Outcomes With Self-Reported Measures of Sleep Duration and Timing in Women Who Are Nulliparous. J Clin Sleep Med. 2018 Dec 15;14(12):2047-2056. doi: 10.5664/jcsm.7534.
- Derived from this study: PubMed 42261656Brubaker LH, Catov JM, Bairey Merz CN, Barnes S, Barone Gibbs B, Booker W, Chung JH, Greenland P, Grobman WA, Khan SS, Lane A, Levine LD, McNeil RB, Miller EC, Muldoon MF, Ray M, Saade GR, Scifres CM, Silver RM, Simhan H, Yee LM, Hauspurg A. Subtypes of Hypertension 2 to 7 Years After First Pregnancy. Hypertension. 2026 Aug;83(8):e26296. doi: 10.1161/HYPERTENSIONAHA.125.26296. Epub 2026 Jun 9.
- Derived from this study: PubMed 41678805Hauspurg A, Grobman W, Jancsura MK, Yee LM, Waks A, Simhan H, Levine LD, Theilen L, Greenland P, McNeil R, Bairey Merz CN, Shahrokni N, Haas D, Khan SS, Venkatesh KK, Catov J. Timing of Hypertensive Disorders of Pregnancy in Nulliparous Individuals and Risk of Incident Chronic Hypertension 2-7 Years Postpartum. Obstet Gynecol. 2026 Jul 1;148(1):e25-e32. doi: 10.1097/AOG.0000000000006191. Epub 2026 Feb 12.
- Derived from this study: PubMed 36138368Haas DM, Yang Z, Parker CB, Chung J, Parry S, Grobman WA, Mercer BM, Simhan HN, Silver RM, Wapner RJ, Saade GR, Greenland P, Merz NB, Reddy UM, Pemberton VL; nuMoM2b study and the nuMoM2b Heart Health Study. Factors associated with duration of breastfeeding in women giving birth for the first time. BMC Pregnancy Childbirth. 2022 Sep 22;22(1):722. doi: 10.1186/s12884-022-05038-7.
- Derived from this study: PubMed 35144521Facco FL, Redline S, Hunter SM, Zee PC, Grobman WA, Silver RM, Louis JM, Pien GW, Mercer B, Chung JH, Bairey Merz CN, Haas DM, Nhan-Chang CL, Simhan HN, Schubert FP, Parry S, Reddy U, Saade GR, Hoffman MK, Levine LD, Wapner RJ, Catov JM, Parker CB. Sleep-disordered Breathing in Pregnancy and after Delivery: Associations with Cardiometabolic Health. Am J Respir Crit Care Med. 2022 May 15;205(10):1202-1213. doi: 10.1164/rccm.202104-0971OC.
- Derived from this study: PubMed 33756281Hawkins M, Parker CB, Redline S, Larkin JC, Zee PP, Grobman WA, Silver RM, Louis JM, Pien GW, Basner RC, Chung JH, Haas DM, Nhan-Chang CL, Simhan HN, Blue NR, Parry S, Reddy U, Facco F; NICHD NuMoM2b and NHLBI NuMoM2b Heart Health Study Networks. Objectively assessed sleep-disordered breathing during pregnancy and infant birthweight. Sleep Med. 2021 May;81:312-318. doi: 10.1016/j.sleep.2021.02.043. Epub 2021 Feb 27.
- Derived from this study: PubMed 33619977Catov JM, McNeil RB, Marsh DJ, Mercer BM, Bairey Merz CN, Parker CB, Pemberton VL, Saade GR, Chen YI, Chung JH, Ehrenthal DB, Grobman WA, Haas DM, Parry S, Polito L, Reddy UM, Silver RM, Simhan HN, Wapner RJ, Kominiarek M, Kreutz R, Levine LD, Greenland P; NHLBI nuMoM2b Heart Health Study. Early Pregnancy Atherogenic Profile in a First Pregnancy and Hypertension Risk 2 to 7 Years After Delivery. J Am Heart Assoc. 2021 Feb;10(5):e017216. doi: 10.1161/JAHA.120.017216. Epub 2021 Feb 23.
- Derived from this study: PubMed 31564189Haas DM, Parker CB, Marsh DJ, Grobman WA, Ehrenthal DB, Greenland P, Bairey Merz CN, Pemberton VL, Silver RM, Barnes S, McNeil RB, Cleary K, Reddy UM, Chung JH, Parry S, Theilen LH, Blumenthal EA, Levine LD, Mercer BM, Simhan H, Polito L, Wapner RJ, Catov J, Chen I, Saade GR; NHLBI nuMoM2b Heart Health Study. Association of Adverse Pregnancy Outcomes With Hypertension 2 to 7 Years Postpartum. J Am Heart Assoc. 2019 Oct;8(19):e013092. doi: 10.1161/JAHA.119.013092. Epub 2019 Sep 30.
- Derived from this study: PubMed 31256258Monk C, Webster RS, McNeil RB, Parker CB, Catov JM, Greenland P, Bairey Merz CN, Silver RM, Simhan HN, Ehrenthal DB, Chung JH, Haas DM, Mercer BM, Parry S, Polito L, Reddy UM, Saade GR, Grobman WA; NICHD nuMoM2b and NHLBI nuMoM2b Heart Health Study Networks. Associations of perceived prenatal stress and adverse pregnancy outcomes with perceived stress years after delivery. Arch Womens Ment Health. 2020 Jun;23(3):361-369. doi: 10.1007/s00737-019-00970-8. Epub 2019 Jun 29.
- Individual participant dataSharing planned: Yes. De-identified data will be made available through an NIH data repository.
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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.
George Saade, M.D. study chair
The University of Texas Medical Branch, Galveston
Brian M. Mercer, MD principal investigator
Case Western Reserve University
Ronald Wapner, MD principal investigator
Columbia University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complicated by Cardiovascular Disorders as Postpartum Condition, Delivered During Previous Episode and Breathing-Related Sleep Disorder, run by RTI International at 15 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 21 inclusion and 1 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 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Hypertension, defined as systolic blood pressure above 140 mm Hg or diastolic blood pressure above 90 mm Hg (time frame: Blood pressures taken at study clinic visit between 2 and 3.5 years postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02231398, which also lists 11 linked publications.
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 16 Feb 2022.