The windsor definition for hyperemesis gravidarum: A multistakeholder international consensus definition.

OBJECTIVE: To develop an international definition for hyperemesis gravidarum to assist in clinical diagnosis and harmonize hyperemesis gravidarum definition for study populations. STUDY DESIGN: A mixed-methods approach was used to identify potential hyperemesis gravidarum definition criteria (i.e. systematic review, semi-structured interviews and closed group sessions with patients and Project Steering Committee input). To reach consensus on the definition we used a web-based Delphi survey with two rounds, followed by a face-to-face consensus development meeting, held in Windsor UK, and a web-based consultation round, in which the provisional hyperemesis gravidarum definition was fed back to the stakeholders. Four stakeholder groups were identified 1) researchers; 2) women with lived experience of hyperemesis gravidarum and their families; 3) obstetric health professionals (obstetricians, gynecologists, midwives); and 4) other health professionals involved in care for women with hyperemesis gravidarum (general practitioners, dieticians, nurses). To reflect the opinions of the international community, stakeholders from countries in all global regions were invited to participate. RESULTS: Twenty-one identified potential criteria entered the Delphi survey. Of the 277 stakeholders invited, 178 completed round one, and 125 (70%) also completed round two. Twenty stakeholders attended the consensus development meeting, representing all stakeholder groups. The consultation round was completed by 96 (54%) stakeholders, of which 92% agreed with the definition as presented. The consensus definition for hyperemesis gravidarum consisted of: start of symptoms in early pregnancy (before 16 weeks gestational age); nausea and vomiting, at least one of which severe; inability to eat and/or drink normally; strongly limits daily living activities. Signs of dehydration were deemed contributory for the definition for hyperemesis gravidarum. CONCLUSIONS: The proposed definition for hyperemesis gravidarum will help clinical studies to achieve more uniformity, and ultimately increasing the value of evidence to inform patient care.

A core outcome set for hyperemesis gravidarum research: an international consensus study.

OBJECTIVE: To develop a core outcome set for trials on the treatment of hyperemesis gravidarum (HG). DESIGN: Identification of outcomes is followed by a modified Delphi survey combined with a consensus development meeting and a consultation round. SETTING: An international web-based survey combined with a consensus development meeting. POPULATION: Stakeholders including researchers; women with lived experience of HG and their families; obstetric health professionals; and other health professionals. METHODS: We used systematic review, semi-structured patient interviews, closed group sessions and Steering Committee input to identify potential core outcomes. We conducted two web-based survey rounds, followed by a face-to-face consensus development meeting and a web-based consultation round. MAIN OUTCOME MEASURES: A core outcome set for research on HG. RESULTS: Fifty-six potential outcomes were identified. The modified Delphi process was completed by 125 stakeholders, the consensus development meeting by 20 stakeholders and the consultation round by 96 stakeholders. Consensus was reached in ten domains on 24 outcomes: nausea; vomiting; inability to tolerate oral fluids or food; dehydration; weight difference; electrolyte imbalance; intravenous fluid treatment; use of medication for hyperemesis gravidarum; hospital treatment; treatment compliance; patient satisfaction; daily functioning; maternal physical or mental or emotional wellbeing; short- and long-term adverse effects of treatment; maternal death; pregnancy complications; considering or actually terminating a wanted pregnancy; preterm birth; small for gestational age; congenital anomalies; neonatal morbidity and offspring death). CONCLUSIONS: This core outcome set will help standardise outcome reporting in HG trials. TWEETABLE ABSTRACT: A core outcome set for treatment of hyperemesis gravidarum in order to create high-quality evidence.

Intrapartum and neonatal mortality in primary midwife-led and secondary obstetrician-led care in the Amsterdam region of the Netherlands: A retrospective cohort study.

OBJECTIVE: To compare intrapartum- and neonatal mortality and intervention rates in term women starting labour in primary midwife-led versus secondary obstetrician-led care. DESIGN: Retrospective cohort study. SETTING: Amsterdam region of the Netherlands. PARTICIPANTS: Women with singleton pregnancies who gave birth beyond 37+0 weeks gestation in the years 2005 up to 2008 and lived in the catchment area of the neonatal intensive care units of both academic hospitals in Amsterdam. Women with a primary caesarean section or a pregnancy complicated by antepartum death or major congenital anomalies were excluded. For women in the midwife-led care group, a home or hospital birth could be planned. MEASUREMENTS: Analysis of linked data from the national perinatal register, and hospital- and midwifery record data. We assessed (unadjusted) relative risks with confidence intervals. Main outcome measures were incidences of intrapartum and neonatal (<28 days) mortality. Secondary outcomes included incidences of caesarean section and vaginal instrumental delivery. FINDINGS: 53,123 women started labour in primary care and 30,166 women in secondary care. Intrapartum and neonatal mortality rates were 37/53,123 (0.70‰) in the primary care group and 24/30,166 (0.80‰) in the secondary care group (relative risk 0.88; 95% CI 0.52-1.46). Women in the primary care group were less likely to deliver by secondary caesarean section (5% versus 16%; RR 0.31; 95% CI 0.30-0.32) or by instrumental delivery (10% versus 13%; RR 0.76; 95% CI 0.73-0.79). KEY CONCLUSIONS: We found a low absolute risk of intrapartum and neonatal mortality, with a comparable risk for women who started labour in primary versus secondary care. The intervention rate was significantly lower in women who started labour in primary care. IMPLICATIONS FOR PRACTICE: These findings suggest that it is possible to identify a group of women at low risk of complications that can start labour in primary care and have low rates of medical interventions whereas perinatal mortality is low.

Perinatal mortality and morbidity up to 28 days after birth among 743 070 low-risk planned home and hospital births: a cohort study based on three merged national perinatal databases.

OBJECTIVE: To compare rates of adverse perinatal outcomes between planned home births versus planned hospital births. DESIGN: A nationwide cohort study. SETTING: The Netherlands. POPULATION: Low-risk women in midwife-led care at the onset of labour. METHODS: Analysis of national registration data. MAIN OUTCOME MEASURES: Intrapartum and neonatal death, Apgar scores, and admission to a neonatal intensive care unit (NICU) within 28 days of birth. RESULTS: Of the total of 814 979 women, 466 112 had a planned home birth and 276 958 had a planned hospital birth. For 71 909 women, their planned place of birth was unknown. The combined intrapartum and neonatal death rates up to 28 days after birth, including cases with discrepancies in the registration of the moment of death, were: for nulliparous women, 1.02‰ for planned home births versus 1.09‰ for planned hospital births, adjusted odds ratio (aOR) 0.99, 95% confidence interval (95% CI) 0.79-1.24; and for parous women, 0.59‰ versus 0.58‰, aOR 1.16, 95% CI 0.87-1.55. The rates of NICU admissions and low Apgar scores did not significantly differ among nulliparous women (NICU admissions up to 28 days, 3.41‰ versus 3.61‰, aOR 1.05, 95% CI 0.92-1.18). Among parous women the rates of Apgar scores below seven and NICU admissions were significantly lower among planned home births (NICU admissions up to 28 days, 1.36 versus 1.95‰, aOR 0.79, 95% CI 0.66-0.93). CONCLUSIONS: We found no increased risk of adverse perinatal outcomes for planned home births among low-risk women. Our results may only apply to regions where home births are well integrated into the maternity care system.

Perinatal mortality and morbidity in a nationwide cohort of 529,688 low-risk planned home and hospital births.

OBJECTIVE: To compare perinatal mortality and severe perinatal morbidity between planned home and planned hospital births, among low-risk women who started their labour in primary care. DESIGN: A nationwide cohort study. SETTING: The entire Netherlands. POPULATION: A total of 529,688 low-risk women who were in primary midwife-led care at the onset of labour. Of these, 321,307 (60.7%) intended to give birth at home, 163,261 (30.8%) planned to give birth in hospital and for 45,120 (8.5%), the intended place of birth was unknown. METHODS: Analysis of national perinatal and neonatal registration data, over a period of 7 years. Logistic regression analysis was used to control for differences in baseline characteristics. MAIN OUTCOME MEASURES: Intrapartum death, intrapartum and neonatal death within 24 hours after birth, intrapartum and neonatal death within 7 days and neonatal admission to an intensive care unit. RESULTS: No significant differences were found between planned home and planned hospital birth (adjusted relative risks and 95% confidence intervals: intrapartum death 0.97 (0.69 to 1.37), intrapartum death and neonatal death during the first 24 hours 1.02 (0.77 to 1.36), intrapartum death and neonatal death up to 7 days 1.00 (0.78 to 1.27), admission to neonatal intensive care unit 1.00 (0.86 to 1.16). CONCLUSIONS: This study shows that planning a home birth does not increase the risks of perinatal mortality and severe perinatal morbidity among low-risk women, provided the maternity care system facilitates this choice through the availability of well-trained midwives and through a good transportation and referral system.