Iris J Grooten1,2,3, Marjette H Koot4,2, Joris Am van der Post4, Joke Mj Bais3, Carrie Ris-Stalpers5, Christiana Naaktgeboren4, Henk A Bremer6, David P van der Ham7, Wieteke M Heidema8, Anjoke Huisjes9, Gunilla Kleiverda10, Simone Kuppens11, Judith Oeh van Laar12, Josje Langenveld13, Flip van der Made14, Mariëlle G van Pampus15, Dimitri Papatsonis16, Marie-José Pelinck17, Paula J Pernet18, Leonie van Rheenen15, Robbert J Rijnders19, Hubertina Cj Scheepers20, Tatjana E Vogelvang21, Ben W Mol22,23, Tessa J Roseboom4,2, Rebecca C Painter4. 1. Departments of Obstetrics and Gynecology and i.j.grooten@amc.uva.nl. 2. Clinical Epidemiology, Biostatistics, and Bioinformatics, and. 3. Department of Obstetrics and Gynaecology, Northwest Hospital Group, Alkmaar, Netherlands. 4. Departments of Obstetrics and Gynecology and. 5. Laboratory of Reproductive Biology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands. 6. Department of Obstetrics and Gynecology, Reinier de Graaf Hospital, Delft, Netherlands. 7. Department of Obstetrics and Gynecology, Martini Hospital, Groningen, Netherlands. 8. Department of Obstetrics and Gynecology, Radboud University Medical Center, Nijmegen, Netherlands. 9. Department of Obstetrics and Gynecology, Gelre Hospital, Apeldoorn, Netherlands. 10. Department of Obstetrics and Gynecology, Flevo Hospital, Almere, Netherlands. 11. Department of Obstetrics and Gynecology, Catharina Hospital, Eindhoven, Netherlands. 12. Department of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, Netherlands. 13. Department of Obstetrics and Gynecology, Zuyderland Hospital, Heerlen, Netherlands. 14. Department of Obstetrics and Gynecology, Franciscus Hospital, Rotterdam, Netherlands. 15. Department of Obstetrics and Gynecology, Onze Lieve Vrouwen Hospital, Amsterdam, Netherlands. 16. Department of Obstetrics and Gynecology, Amphia Hospital, Breda, Netherlands. 17. Department of Obstetrics and Gynecology, Scheper Hospital, Emmen, Netherlands. 18. Department of Obstetrics and Gynecology, Spaarne Hospital, Haarlem, Netherlands. 19. Department of Obstetrics and Gynecology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands. 20. Department of Obstetrics and Gynecology, Maastricht University Medical Center, Maastricht, Netherlands. 21. Department of Obstetrics and Gynecology, Diakonessenhuis, Utrecht, Netherlands. 22. Robinson Institute, School of Pediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia; and. 23. The South Australian Health and Medical Research Institute, Adelaide, Australia.
Abstract
Background: Hyperemesis gravidarum (HG) leads to dehydration, poor nutritional intake, and weight loss. HG has been associated with adverse pregnancy outcomes such as low birth weight. Information about the potential effectiveness of treatments for HG is limited.Objective: We hypothesized that in women with HG, early enteral tube feeding in addition to standard care improves birth weight.Design: We performed a multicenter, open-label randomized controlled trial [Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding (MOTHER)] in 19 hospitals in the Netherlands. A total of 116 women hospitalized for HG between 5 and 20 wk of gestation were randomly allocated to enteral tube feeding for ≥7 d in addition to standard care with intravenous rehydration and antiemetic treatment or to standard care alone. Women were encouraged to continue tube feeding at home. On the basis of our power calculation, a sample size of 120 women was anticipated. Analyses were performed according to the intention-to-treat principle. Results: Between October 2014 and March 2016 we randomly allocated 59 women to enteral tube feeding and 57 women to standard care. The mean ± SD birth weight was 3160 ± 770 g in the enteral tube feeding group compared with 3200 ± 680 g in the standard care group (mean difference: -40 g, 95% CI: -230, 310 g). Secondary outcomes, including maternal weight gain, duration of hospital stay, readmission rate, nausea and vomiting symptoms, decrease in quality of life, psychological distress, prematurity, and small-for-gestational-age, also were comparable. Of the women allocated to enteral tube feeding, 28 (47%) were treated according to protocol. Enteral tube feeding was discontinued within 7 d of placement in the remaining women, primarily because of its adverse effects (34%).Conclusions: In women with HG, early enteral tube feeding does not improve birth weight or secondary outcomes. Many women discontinued tube feeding because of discomfort, suggesting that it is poorly tolerated as an early routine treatment of HG. This trial was registered at www.trialregister.nl as NTR4197.
RCT Entities:
Background: Hyperemesis gravidarum (HG) leads to dehydration, poor nutritional intake, and weight loss. HG has been associated with adverse pregnancy outcomes such as low birth weight. Information about the potential effectiveness of treatments for HG is limited.Objective: We hypothesized that in women with HG, early enteral tube feeding in addition to standard care improves birth weight.Design: We performed a multicenter, open-label randomized controlled trial [Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding (MOTHER)] in 19 hospitals in the Netherlands. A total of 116 women hospitalized for HG between 5 and 20 wk of gestation were randomly allocated to enteral tube feeding for ≥7 d in addition to standard care with intravenous rehydration and antiemetic treatment or to standard care alone. Women were encouraged to continue tube feeding at home. On the basis of our power calculation, a sample size of 120 women was anticipated. Analyses were performed according to the intention-to-treat principle. Results: Between October 2014 and March 2016 we randomly allocated 59 women to enteral tube feeding and 57 women to standard care. The mean ± SD birth weight was 3160 ± 770 g in the enteral tube feeding group compared with 3200 ± 680 g in the standard care group (mean difference: -40 g, 95% CI: -230, 310 g). Secondary outcomes, including maternal weight gain, duration of hospital stay, readmission rate, nausea and vomiting symptoms, decrease in quality of life, psychological distress, prematurity, and small-for-gestational-age, also were comparable. Of the women allocated to enteral tube feeding, 28 (47%) were treated according to protocol. Enteral tube feeding was discontinued within 7 d of placement in the remaining women, primarily because of its adverse effects (34%).Conclusions: In women with HG, early enteral tube feeding does not improve birth weight or secondary outcomes. Many women discontinued tube feeding because of discomfort, suggesting that it is poorly tolerated as an early routine treatment of HG. This trial was registered at www.trialregister.nl as NTR4197.
Authors: Kelly Nijsten; Marjette H Koot; Joris A M van der Post; Joke M J Bais; Carrie Ris-Stalpers; Christiana Naaktgeboren; Henk A Bremer; David P van der Ham; Wieteke M Heidema; Anjoke Huisjes; Gunilla Kleiverda; Simone M Kuppens; Judith O E H van Laar; Josje Langenveld; Flip van der Made; Dimitri Papatsonis; Marie-José Pelinck; Paula J Pernet; Leonie van Rheenen-Flach; Robbert J Rijnders; Hubertina C J Scheepers; Sarah E Siegelaar; Tatjana Vogelvang; Ben W Mol; Tessa J Roseboom; Iris J Grooten; Rebecca C Painter Journal: Acta Obstet Gynecol Scand Date: 2021-03-12 Impact factor: 4.544
Authors: Anne Ostenfeld; Tonny Studsgaard Petersen; Tina Bergmann Futtrup; Jon Trærup Andersen; Andreas Kryger Jensen; Hanne Brix Westergaard; Lars Henning Pedersen; Ellen Christine Leth Løkkegaard Journal: BMJ Open Date: 2020-03-24 Impact factor: 2.692
Authors: Kelly Nijsten; Loïs van der Minnen; Hanke M G Wiegers; Marjette H Koot; Saskia Middeldorp; Tessa J Roseboom; Iris J Grooten; Rebecca C Painter Journal: Br J Nutr Date: 2021-07-30 Impact factor: 4.125