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A description of the methods of the Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be (nuMoM2b)

Published:January 31, 2015DOI:https://doi.org/10.1016/j.ajog.2015.01.019

      Objective

      The primary aim of the “Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be” is to determine maternal characteristics, which include genetic, physiologic response to pregnancy, and environmental factors that predict adverse pregnancy outcomes.

      Study Design

      Nulliparous women in the first trimester of pregnancy were recruited into an observational cohort study. Participants were seen at 3 study visits during pregnancy and again at delivery. We collected data from in-clinic interviews, take-home surveys, clinical measurements, ultrasound studies, and chart abstractions. Maternal biospecimens (serum, plasma, urine, cervicovaginal fluid) at antepartum study visits and delivery specimens (placenta, umbilical cord, cord blood) were collected, processed, and stored. The primary outcome of the study was defined as pregnancy ending at <37+0 weeks’ gestation. Key study hypotheses involve adverse pregnancy outcomes of spontaneous preterm birth, preeclampsia, and fetal growth restriction.

      Results

      We recruited 10,037 women to the study. Basic characteristics of the cohort at screening are reported.

      Conclusion

      The “Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be” cohort study methods and procedures can help investigators when they plan future projects.

      Key words

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      References

        • Martin J.A.
        • Hamilton B.E.
        • Osterman M.
        • Curtin S.C.
        • Mathews T.J.
        Births: final data for 2012.
        Nat Vital Stat Rep. 2013; 62: 1-68
        • Blencowe H.
        • Cousens S.
        • Oestergaard M.Z.
        • et al.
        National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications.
        Lancet. 2012; 379: 2162-2172
        • Chang H.H.
        • Larson J.
        • Blencowe H.
        • et al.
        Preventing preterm births: analysis of trends and potential reductions with interventions in 39 countries with very high human development index.
        Lancet. 2013; 381: 223-234
      1. Committee on Practice Bulletins–Obstetrics: American College of Obstetricians and Gynecologists. Practice bulletin no. 130: prediction and prevention of preterm birth.
        Obstet Gynecol. 2012; 120: 964-973
        • North R.A.
        • McCowan L.M.
        • Dekker G.A.
        • et al.
        Clinical risk prediction for pre-eclampsia in nulliparous women: development of model in international prospective cohort.
        BMJ. 2011; 342: d1875
        • Seed P.T.
        • Chappell L.C.
        • Black M.A.
        • et al.
        Prediction of preeclampsia and delivery of small for gestational age babies based on a combination of clinical risk factors in high-risk women.
        Hypertens Pregnancy. 2011; 30: 58-73
        • Conde-Agudelo A.
        • Papageorghiou A.T.
        • Kennedy S.H.
        • Villar J.
        Novel biomarkers for the prediction of the spontaneous preterm birth phenotype: a systematic review and meta-analysis.
        BJOG. 2011; 118: 1042-1054
        • Lee K.A.
        • Chang M.H.
        • Park M.-H.
        • et al.
        A model for prediction of spontaneous preterm birth in asymptomatic women.
        J Womens Health. 2011; 20: 1825-1831
        • Myatt L.
        • Clifton R.G.
        • Roberts J.M.
        • et al.
        First-trimester prediction of preeclampsia in nulliparous women at low risk.
        Obstet Gynecol. 2012; 119: 1234-1242
        • Zhong Y.
        • Tuuli M.
        • Odibo A.O.
        First-trimester assessment of placenta function and the prediction of preeclampsia and intrauterine growth restriction.
        Prenatal Diagn. 2010; 30: 293-308
        • MacDorman M.F.
        • Kirmeyer S.
        • Wilson E.C.
        Fetal and perinatal mortality: United States, 2006.
        Nat Vital Stat Rep. 2012; 60: 1-23
        • Leviton A.
        • Paneth N.
        • Reuss M.L.
        • et al.
        Maternal infection, fetal inflammatory response, and brain damage in very low birth weight infants: Developmental Epidemiology Network Investigators.
        Pediatr Res. 1999; 46: 566-575
        • Dammann O.
        • Leviton A.
        • Gappa M.
        • Dammann C.E.
        Lung and brain damage in preterm newborns, and their association with gestational age, prematurity subgroup, infection/inflammation and long term outcome.
        BJOG. 2005; 112: 4-9
        • Duley L.
        • Henderson-Smart D.J.
        • Meher S.
        • King J.F.
        Antiplatelet agents for preventing pre-eclampsia and its complications.
        Cochrane Database Syst Rev. 2007; : CD004659
        • Subtil D.
        • Goeusse P.
        • Puech F.
        • et al.
        Aspirin (100 mg) used for prevention of pre-eclampsia in nulliparous women: the Essai Regional Aspirine Mere-Enfant study (Part 1).
        BJOG. 2003; 110: 475-484
        • Crispi F.
        • Dominguez C.
        • Llurba E.
        • Martin-Gallan P.
        • Cabero L.
        • Gratacos E.
        Placental angiogenic growth factors and uterine artery Doppler findings for characterization of different subsets in preeclampsia and in isolated intrauterine growth restriction.
        Am J Obstet Gynecol. 2006; 195: 201-207
        • Odibo A.O.
        • Zhong Y.
        • Longtine M.
        • et al.
        First-trimester serum analytes, biophysical tests and the association with pathological morphometry in the placenta of pregnancies with preeclampsia and fetal growth restriction.
        Placenta. 2011; 32: 333-338
        • Pepe M.S.
        • Feng Z.
        • Huang Y.
        • et al.
        Integrating the predictiveness of a marker with its performance as a classifier.
        Am J Epidemiol. 2008; 167: 362-368
        • Bastek J.A.
        • Sammel M.D.
        • Srinivas S.K.
        • et al.
        Clinical prediction rules for preterm birth in patients presenting with preterm labor.
        Obstet Gynecol. 2012; 119: 1119-1128
        • Goetzinger K.R.
        • Cahill A.G.
        • Kemna J.
        • Odibo L.
        • Macones G.A.
        • Odibo A.O.
        First-trimester prediction of preterm birth using ADAM12, PAPP-A, uterine artery Doppler, and maternal characteristics.
        Prenat Diagn. 2012; 32: 1002-1007
        • Bahado-Singh R.O.
        • Akolekar R.
        • Mandal R.
        • et al.
        Metabolomics and first-trimester prediction of early-onset preeclampsia.
        J Matern Fetal Neonat Med. 2012; 25: 1840-1847
        • Parra-Cordero M.
        • Rodrigo R.
        • Barja P.
        • et al.
        Prediction of early and late pre-eclampsia from maternal characteristics, uterine artery Doppler and markers of vasculogenesis during first trimester of pregnancy.
        Ultrasound Obstet Gynecol. 2013; 41: 538-544
        • Kwon H.-S.
        • Kim Y.-H.
        • Park Y.-W.
        Uterine artery Doppler velocimetry and maternal weight gain by the mid-second trimester for prediction of fetal growth restriction.
        Acta Obstett Gynecol Scand. 2008; 87: 1291-1295
        • Melchiorre K.
        • Leslie K.
        • Prefumo F.
        • Bhide A.
        • Thilaganathan B.
        First-trimester uterine artery Doppler indices in the prediction of small-for-gestational age pregnancy and intrauterine growth restriction.
        Ultrasound Obstet Gynecol. 2009; 33: 524-529
        • Onalan R.
        • Onalan G.
        • Gunenc Z.
        • Karabulut E.
        Combining 2nd-trimester maternal serum homocysteine levels and uterine artery Doppler for prediction of preeclampsia and isolated intrauterine growth restriction.
        Gynecol Obstet Investig. 2006; 61: 142-148
        • Goldenberg R.L.
        • Iams J.D.
        • Mercer B.M.
        • et al.
        The preterm prediction study: the value of new vs standard risk factors in predicting early and all spontaneous preterm births: NICHD MFMU Network.
        Am J Public Health. 1998; 88: 233-238
        • Akolekar R.
        • Syngelaki A.
        • Sarquis R.
        • Zvanca M.
        • Nicolaides K.H.
        Prediction of early, intermediate and late pre-eclampsia from maternal factors, biophysical and biochemical markers at 11-13 weeks.
        Prenat Diagn. 2011; 31: 66-74
        • Poon L.C.
        • Kametas N.A.
        • Maiz N.
        • Akolekar R.
        • Nicolaides K.H.
        First-trimester prediction of hypertensive disorders in pregnancy.
        Hypertension. 2009; 53: 812-818
        • American College of Obstetricians and Gynecologists
        Report of the American College of Obstetricians and Gynecologists’ Task Force on Hypertension in Pregnancy.
        Obstet Gynecol. 2013; 122: 1122-1131
        • Martin A.M.
        • Bindra R.
        • Curcio P.
        • Cicero S.
        • Nicolaides K.H.
        Screening for pre-eclampsia and fetal growth restriction by uterine artery Doppler at 11-14 weeks of gestation.
        Ultrasound Obstet Gynecol. 2001; 18: 583-586
        • Papageorghiou A.T.
        • Yu C.K.
        • Bindra R.
        • Pandis G.
        • Nicolaides K.H.
        Multicenter screening for pre-eclampsia and fetal growth restriction by transvaginal uterine artery Doppler at 23 weeks of gestation.
        Ultrasound Obstet Gynecol. 2001; 18: 441-449
        • Davey M.A.
        • Watson L.
        • Rayner J.A.
        • Rowlands S.
        Risk scoring systems for predicting preterm birth with the aim of reducing associated adverse outcomes.
        Cochrane Database Syst Rev. 2011; : CD004902
        • Honest H.
        • Forbes C.A.
        • Duree K.H.
        • et al.
        Screening to prevent spontaneous preterm birth: systematic reviews of accuracy and effectiveness literature with economic modelling.
        Health Technol Assess. 2009; 13: 1-627
        • Esplin M.S.
        • Merrell K.
        • Goldenberg R.
        • et al.
        Proteomic identification of serum peptides predicting subsequent spontaneous preterm birth.
        Am J Obstet Gynecol. 2011; 204: 391.e1-391.e8
        • Hadlock F.P.
        • Shah Y.P.
        • Kanon D.J.
        • Lindsey J.V.
        Fetal crown-rump length: reevaluation of relation to menstrual age (5-18 weeks) with high-resolution real-time US.
        Radiology. 1992; 182: 501-505
        • Arozullah A.M.
        • Yarnold P.R.
        • Bennett C.L.
        • et al.
        Development and validation of a short-form, rapid estimate of adult literacy in medicine.
        Med Care. 2007; 45: 1026-1033
        • Block G.
        • Woods M.
        • Potosky A.
        • Clifford C.
        Validation of a self-administered diet history questionnaire using multiple diet records.
        J Clin Epidemiol. 1990; 43: 1327-1335
        • Hibbard J.H.
        • Mahoney E.R.
        • Stockard J.
        • Tusler M.
        Development and testing of a short form of the patient activation measure.
        Health Serv Res. 2005; 40: 1918-1930
        • Krieger N.
        • Smith K.
        • Naishadham D.
        • Hartman C.
        • Barbeau E.M.
        Experiences of discrimination: validity and reliability of a self-report measure for population health research on racism and health.
        Soc Sci Med. 2005; 61: 1576-1596
        • Zimet G.D.
        • Powell S.S.
        • Farley G.K.
        • Werkman S.
        • Berkoff K.A.
        Psychometric characteristics of the multidimensional scale of perceived social support.
        J Pers Assess. 1990; 55: 610-617
        • DiPietro J.A.
        • Christensen A.L.
        • Costigan K.A.
        The pregnancy experience scale-brief version.
        J Psychosom Obstet Gynaecol. 2008; 29: 262-267
        • Connor K.M.
        • Davidson J.R.
        Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC).
        Depress Anxiety. 2003; 18: 76-82
        • Levine D.W.
        • Kaplan R.M.
        • Kripke D.F.
        • Bowen D.J.
        • Naughton M.J.
        • Shumaker S.A.
        Factor structure and measurement invariance of the Women’s Health Initiative Insomnia Rating Scale.
        Psychol Assess. 2003; 15: 123-136
        • Johns M.W.
        Reliability and factor analysis of the Epworth Sleepiness Scale.
        Sleep. 1992; 15: 376-381
        • Allen R.P.
        • Picchietti D.
        • Hening W.A.
        • Trenkwalder C.
        • Walters A.S.
        • Montplaisi J.
        Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology: a report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health.
        Sleep Med. 2003; 4: 101-119
        • Netzer N.C.
        • Stoohs R.A.
        • Netzer C.M.
        • Clark K.
        • Strohl K.P.
        Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome.
        Ann Intern Med. 1999; 131: 485-491
      2. Spielberger CD. Manual for the state-trait anxiety inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.

        • Cox J.L.
        • Holden J.M.
        • Sagovsky R.
        Detection of postnatal depression: development of the 10-item Edinburgh Postnatal Depression Scale.
        Br J Psychiatry. 1987; 150: 782-786
        • Cohen S.
        • Kamarck T.
        • Mermelstein R.
        A global measure of perceived stress.
        J Health Soc Behav. 1983; 24: 385-396
        • Koren G.
        • Boskovic R.
        • Hard M.
        • Maltepe C.
        • Navioz Y.
        • Einarson A.
        Motherisk-PUQE (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy.
        Am J Obstet Gynecol. 2002; 186: S228-S231

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