- Email: [email protected]
Optimum time for pregnancy after bariatric surgery
Author’s Accepted Manuscript Optimum time for pregnancy after bariatric surgery Kamal K. Mahawar, Yitka Graham, Peter K. Small
www.elsevier.com/locate/buildenv
PII: DOI: Reference:
S1550-7289(16)30077-6 http://dx.doi.org/10.1016/j.soard.2016.05.005 SOARD2672
To appear in: Surgery for Obesity and Related Diseases Received date: 29 April 2016 Revised date: 30 April 2016 Accepted date: 2 May 2016 Cite this article as: Kamal K. Mahawar, Yitka Graham and Peter K. Small, Optimum time for pregnancy after bariatric surgery, Surgery for Obesity and Related Diseases, http://dx.doi.org/10.1016/j.soard.2016.05.005 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Title: Optimum Time for Pregnancy after Bariatric Surgery
Short Running Title: Bariatric Surgery and Pregnancy
Type of Article: Controversies in Bariatric Surgery
Authors:
Kamal K Mahawar1, 2 MS MSc FRCSEd Yitka Graham1, 2 BSc (Hons) Peter K Small1 RD MD FRCSEd
Department and Institute: 1. Bariatric Unit, Sunderland Royal Hospital, Sunderland SR4 7TP, United Kingdom 2. Department of Pharmacy, Health and Well-being, University of Sunderland, Sunderland SR1 3SD, United Kingdom
Author for Correspondence:
Kamal K Mahawar Consultant Surgeon Sunderland Royal Hospital, Sunderland SR4 7TP, UK Email: [email protected] Tel: +44 (0) 191- 5656256
Key Words: Bariatric Surgery, Pregnancy, Gastric Bypass, Sleeve Gastrectomy, Gastric Banding, One Anastomosis Gastric Bypass, Mini Gastric Bypass, Pregnancy, Miscarriage, Abortion Source(s) of Funding: None
1
Various professional guidelines recommend different waiting time periods for pregnancy after bariatric surgery. Though both the British Obesity and Metabolic Surgery Society (BOMSS) (1) and the American Society for Metabolic and Bariatric Surgery (ASMBS) (2) recommend that patients avoid pregnancy for 12 - 18 months after surgery to ensure a stable weight has been reached, the American College of Obstetricians and Gynecologists (ACOG) recommends (3) a wait of 12 - 24 months and in United Kingdom, The Royal College of Obstetricians and Gynaecologists (RCOG) recommends (4) a "more personalised approach, taking into account maternal age and balancing theoretical nutritional risk against the risk that delaying pregnancy in older women who have undertaken bariatric surgery may further compromise their chance of conceiving a healthy child."
The fact that BOMSS, ASMBS, and ACOG also provide a range rather than a fixed time period, also probably implies a personalized approach, though within the time range mentioned within the guidance. However, no further information is provided regarding the evidence base supporting this recommendation. Moreover, criteria to determine the most optimum time for pregnancy after bariatric surgery for any individual patient have not been discussed in any depth. This becomes even more important in the light of studies showing that viable pregnancies conceived before this arbitrary time period do not have inferior outcomes to those that are conceived later (5-8). The results of these studies may, however, have been different had they separated patients into categories depending on whether or not their weight had become stabilized, instead of focussing
2
on arbitrary time periods. Moreover, these studies focused on successful pregnancies and did not take into account the rates of spontaneous abortions, which again one suspects might have been different in women who conceived after their weight had stabilized, in comparison to those who were still losing weight at the time of conception.
It is important to fully understand the effect of bariatric surgery on pregnancy outcomes. Rapid weight loss seen in the initial months after bariatric surgery improves fertility (9), and is clearly a beneficial outcome for a large proportion of young women undergoing bariatric surgery, who regard the ability to conceive in future an important issue (10). Though currently unclear, it appears to be mediated through regularization of the menstrual cycle and resumption of ovulation (9). However, this rapid weight loss also compromises fetal growth and survival, resulting in a high miscarriage rate (8,11). This is the underlying reason behind the advice to delay pregnancy until a stable weight has been reached, and use of appropriate contraception until then. However, we know that knowledge and awareness of information on contraceptive advice after bariatric surgery is lacking amongst both patients and the healthcare professionals (12) and as a result, many women do not use any contraception at all after bariatric surgery (13). This means some women fall pregnant too soon when they are still losing significant weight and this is probably why bariatric surgery has been found to be associated with a higher risk of "small for gestational age" and preterm births (14-15) in population-based matched studies. One suspects that if there were studies that examined patients who had waited for their weights to stabilize before conceiving, the results of pregnancy in patients post
3
bariatric surgery would be better for even these two outcome measures. Future studies examining the impact of bariatric surgery on pregnancy outcomes should exclude pregnancies conceived intentionally or unintentionally during the phase of rapid weight loss as they are bound to have poorer outcomes. It is worth reminding ourselves that even in these population-based studies, the results were superior in the bariatric surgery cohort for many other outcome measures.
The advice to ensure that a stable weight has been reached prior to conception is sensible to avoid spontaneous abortion and Intra-uterine growth retardation. It also allows the women to reach their weight loss goals. However, imposing a fixed time limit on all women disregards individual patient characteristics as well as the fact that different bariatric surgical procedures have different weight loss curves. For example, the weight loss with a gastric bypass has a much steeper trajectory to that with a gastric band. The weight loss curve may also depend on a patient's starting weight and body mass index (BMI). It is conceivable that weight of a woman with a starting BMI of 35 kg/m2 has plateaued after 6 months; whereas, somebody with a BMI of 60 kg/m 2 continues to lose weight well into the second year after surgery.
As stated in the recommendation from the RCOG (4), any unnecessary delay may further reduce the chances of conceiving a healthy child. Moreover, weight regain is a reality after bariatric surgery and it is possible that a patient who achieved her peak weight loss at 8 months has actually gained some weight by the time she reaches the 18-24 month
4
mark after surgery and, thus, missed her peak fertility window. The somewhat arbitrary time period of 18-24 months was probably recommended because most patients do not lose much weight after this time period. However, it cannot be guaranteed and there may well be some patients who go on to lose significant weight beyond the 2-year mark. Therefore, any arbitrary time limit completely disregards the weight loss trajectory of an individual patient and the advice given may well not be appropriate for the individual concerned.
We believe it is the time the bariatric community reconsiders its advice on the most appropriate timing of pregnancy. The advice needs to be individualized and any blanket recommendation is neither evidence-based nor patient-centred. It may even have harmful consequences for the fetus if the woman is still experiencing significant weight loss after the arbitrary time period recommended in these guidelines. Instead of arbitrary fixed time periods as suggested in many guidelines, we believe women should be advised to avoid pregnancy, using appropriate contraception, until their weight has been stable for at least 2 months. A simple, uniform message backed up by adequate provisions for post bariatric surgery contraception advice is what these women need. Conflict of Interest Statement: The authors declare that they have no conflict of interest. Statement of Human and Animal Rights: The manuscript did not use any human or animal subjects Statement of Informed Consent: Not Applicable
5
References: 1. O’Kane M, Pinkney J, Aasheim E, Barth J, Batterham R, Welbourn R. BOMSS Guidelines on perioperative and postoperative biochemical monitoring and micronutrient replacement for patients undergoing bariatric surgery. Adopted by BOMSS Council September 2014. http://www.bomss.org.uk/wpcontent/uploads/2014/09/BOMSS-guidelines-Final-version1Oct14.pdf Last Accessed on 26th April’ 2016 2. Mechanick JI, Youdim A, Jones DB, et al. American Association of Clinical Endocrinologists; Obesity Society; American Society for Metabolic & Bariatric Surgery. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient--2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Obesity (Silver Spring). 2013; 21 Suppl 1: S1-27. doi: 10.1002/oby.20461. 3. American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 105: bariatric surgery and pregnancy. Obstet Gynecol 2009; 113(6): 1405-13. 4. Royal College of Obstetricians and Gynaecologists. Scientific Impact Paper No. 17. The Role of Bariatric Surgery in Improving Reproductive Health. https://www.rcog.org.uk/globalassets/documents/guidelines/scientific-impactpapers/sip_17.pdf Last Accessed on 26th April’ 2016. 5. Dao T, Kuhn J, Ehmer D, Fisher T, McCarty T. Pregnancy outcomes after gastricbypass surgery. Am J Surg 2006; 192(6): 762-6. 6. Wax JR, Cartin A, Wolff R, Lepich S, Pinette MG, Blackstone J. Pregnancy following gastric bypass for morbid obesity: effect of surgery-to-conception interval on maternal and neonatal outcomes. Obes Surg 2008; 18(12): 1517-21. 7. Patel JA, Patel NA, Thomas RL, Nelms JK, Colella JJ. Pregnancy outcomes after laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis 2008; 4(1): 39-45. 8. Bebber FE, Rizzolli J, Casagrande DS, et al. Pregnancy after bariatric surgery: 39
6
pregnancies follow-up in a multidisciplinary team. Obes Surg 2011; 21(10): 154651. 9. Milone M, De Placido G, Musella M, et al. Incidence of Successful Pregnancy After Weight Loss Interventions in Infertile Women: a Systematic Review and Meta-Analysis of the Literature. Obes Surg 2016; 26(2): 443-51. 10. Gosman GG, King WC, Schrope B, et al. Reproductive health of women electing bariatric surgery. Fertil Steril 2010; 94(4): 1426-31. 11. Goldman RH, Missmer SA, Robinson MK, Farland LV, Ginsburg ES. Reproductive Outcomes Differ Following Roux-en-Y Gastric Bypass and Adjustable Gastric Band Compared with Those of an Obese Non-Surgical Group. Obes Surg. 2016 Apr 6. [Epub ahead of print] 12. Graham YN, Mansour D, Small PK, et al. A Survey of Bariatric Surgical and Reproductive Health Professionals' Knowledge and Provision of Contraception to Reproductive-Aged Bariatric Surgical Patients. Obes Surg 2016 Jan 22. [Epub ahead of print] 13. Ginstman C, Frisk J, Ottosson J, Brynhildsen J. Contraceptive Use Before and After Gastric Bypass: a Questionnaire Study. Obes Surg 2015; 25(11): 2066-70. 14. Johansson K, Cnattingius S, Näslund I, et al. Outcomes of pregnancy after bariatric surgery. N Engl J Med 2015; 372(9): 814-24. 15. Kjær MM, Lauenborg J, Breum BM, Nilas L. The risk of adverse pregnancy outcome after bariatric surgery: a nationwide register-based matched cohort study. Am J Obstet Gynecol 2013; 208(6): 464.e1-5.
7
Abbreviations: BOMSS: British Obesity and Metabolic Surgery Society ASMBS: American Society for Metabolic and Bariatric Surgery ACOG: American College of Obstetricians and Gynaecologists RCOG: Royal College of Obstetricians and Gynaecologists
8
www.elsevier.com/locate/buildenv
PII: DOI: Reference:
S1550-7289(16)30077-6 http://dx.doi.org/10.1016/j.soard.2016.05.005 SOARD2672
To appear in: Surgery for Obesity and Related Diseases Received date: 29 April 2016 Revised date: 30 April 2016 Accepted date: 2 May 2016 Cite this article as: Kamal K. Mahawar, Yitka Graham and Peter K. Small, Optimum time for pregnancy after bariatric surgery, Surgery for Obesity and Related Diseases, http://dx.doi.org/10.1016/j.soard.2016.05.005 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Title: Optimum Time for Pregnancy after Bariatric Surgery
Short Running Title: Bariatric Surgery and Pregnancy
Type of Article: Controversies in Bariatric Surgery
Authors:
Kamal K Mahawar1, 2 MS MSc FRCSEd Yitka Graham1, 2 BSc (Hons) Peter K Small1 RD MD FRCSEd
Department and Institute: 1. Bariatric Unit, Sunderland Royal Hospital, Sunderland SR4 7TP, United Kingdom 2. Department of Pharmacy, Health and Well-being, University of Sunderland, Sunderland SR1 3SD, United Kingdom
Author for Correspondence:
Kamal K Mahawar Consultant Surgeon Sunderland Royal Hospital, Sunderland SR4 7TP, UK Email: [email protected] Tel: +44 (0) 191- 5656256
Key Words: Bariatric Surgery, Pregnancy, Gastric Bypass, Sleeve Gastrectomy, Gastric Banding, One Anastomosis Gastric Bypass, Mini Gastric Bypass, Pregnancy, Miscarriage, Abortion Source(s) of Funding: None
1
Various professional guidelines recommend different waiting time periods for pregnancy after bariatric surgery. Though both the British Obesity and Metabolic Surgery Society (BOMSS) (1) and the American Society for Metabolic and Bariatric Surgery (ASMBS) (2) recommend that patients avoid pregnancy for 12 - 18 months after surgery to ensure a stable weight has been reached, the American College of Obstetricians and Gynecologists (ACOG) recommends (3) a wait of 12 - 24 months and in United Kingdom, The Royal College of Obstetricians and Gynaecologists (RCOG) recommends (4) a "more personalised approach, taking into account maternal age and balancing theoretical nutritional risk against the risk that delaying pregnancy in older women who have undertaken bariatric surgery may further compromise their chance of conceiving a healthy child."
The fact that BOMSS, ASMBS, and ACOG also provide a range rather than a fixed time period, also probably implies a personalized approach, though within the time range mentioned within the guidance. However, no further information is provided regarding the evidence base supporting this recommendation. Moreover, criteria to determine the most optimum time for pregnancy after bariatric surgery for any individual patient have not been discussed in any depth. This becomes even more important in the light of studies showing that viable pregnancies conceived before this arbitrary time period do not have inferior outcomes to those that are conceived later (5-8). The results of these studies may, however, have been different had they separated patients into categories depending on whether or not their weight had become stabilized, instead of focussing
2
on arbitrary time periods. Moreover, these studies focused on successful pregnancies and did not take into account the rates of spontaneous abortions, which again one suspects might have been different in women who conceived after their weight had stabilized, in comparison to those who were still losing weight at the time of conception.
It is important to fully understand the effect of bariatric surgery on pregnancy outcomes. Rapid weight loss seen in the initial months after bariatric surgery improves fertility (9), and is clearly a beneficial outcome for a large proportion of young women undergoing bariatric surgery, who regard the ability to conceive in future an important issue (10). Though currently unclear, it appears to be mediated through regularization of the menstrual cycle and resumption of ovulation (9). However, this rapid weight loss also compromises fetal growth and survival, resulting in a high miscarriage rate (8,11). This is the underlying reason behind the advice to delay pregnancy until a stable weight has been reached, and use of appropriate contraception until then. However, we know that knowledge and awareness of information on contraceptive advice after bariatric surgery is lacking amongst both patients and the healthcare professionals (12) and as a result, many women do not use any contraception at all after bariatric surgery (13). This means some women fall pregnant too soon when they are still losing significant weight and this is probably why bariatric surgery has been found to be associated with a higher risk of "small for gestational age" and preterm births (14-15) in population-based matched studies. One suspects that if there were studies that examined patients who had waited for their weights to stabilize before conceiving, the results of pregnancy in patients post
3
bariatric surgery would be better for even these two outcome measures. Future studies examining the impact of bariatric surgery on pregnancy outcomes should exclude pregnancies conceived intentionally or unintentionally during the phase of rapid weight loss as they are bound to have poorer outcomes. It is worth reminding ourselves that even in these population-based studies, the results were superior in the bariatric surgery cohort for many other outcome measures.
The advice to ensure that a stable weight has been reached prior to conception is sensible to avoid spontaneous abortion and Intra-uterine growth retardation. It also allows the women to reach their weight loss goals. However, imposing a fixed time limit on all women disregards individual patient characteristics as well as the fact that different bariatric surgical procedures have different weight loss curves. For example, the weight loss with a gastric bypass has a much steeper trajectory to that with a gastric band. The weight loss curve may also depend on a patient's starting weight and body mass index (BMI). It is conceivable that weight of a woman with a starting BMI of 35 kg/m2 has plateaued after 6 months; whereas, somebody with a BMI of 60 kg/m 2 continues to lose weight well into the second year after surgery.
As stated in the recommendation from the RCOG (4), any unnecessary delay may further reduce the chances of conceiving a healthy child. Moreover, weight regain is a reality after bariatric surgery and it is possible that a patient who achieved her peak weight loss at 8 months has actually gained some weight by the time she reaches the 18-24 month
4
mark after surgery and, thus, missed her peak fertility window. The somewhat arbitrary time period of 18-24 months was probably recommended because most patients do not lose much weight after this time period. However, it cannot be guaranteed and there may well be some patients who go on to lose significant weight beyond the 2-year mark. Therefore, any arbitrary time limit completely disregards the weight loss trajectory of an individual patient and the advice given may well not be appropriate for the individual concerned.
We believe it is the time the bariatric community reconsiders its advice on the most appropriate timing of pregnancy. The advice needs to be individualized and any blanket recommendation is neither evidence-based nor patient-centred. It may even have harmful consequences for the fetus if the woman is still experiencing significant weight loss after the arbitrary time period recommended in these guidelines. Instead of arbitrary fixed time periods as suggested in many guidelines, we believe women should be advised to avoid pregnancy, using appropriate contraception, until their weight has been stable for at least 2 months. A simple, uniform message backed up by adequate provisions for post bariatric surgery contraception advice is what these women need. Conflict of Interest Statement: The authors declare that they have no conflict of interest. Statement of Human and Animal Rights: The manuscript did not use any human or animal subjects Statement of Informed Consent: Not Applicable
5
References: 1. O’Kane M, Pinkney J, Aasheim E, Barth J, Batterham R, Welbourn R. BOMSS Guidelines on perioperative and postoperative biochemical monitoring and micronutrient replacement for patients undergoing bariatric surgery. Adopted by BOMSS Council September 2014. http://www.bomss.org.uk/wpcontent/uploads/2014/09/BOMSS-guidelines-Final-version1Oct14.pdf Last Accessed on 26th April’ 2016 2. Mechanick JI, Youdim A, Jones DB, et al. American Association of Clinical Endocrinologists; Obesity Society; American Society for Metabolic & Bariatric Surgery. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient--2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Obesity (Silver Spring). 2013; 21 Suppl 1: S1-27. doi: 10.1002/oby.20461. 3. American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 105: bariatric surgery and pregnancy. Obstet Gynecol 2009; 113(6): 1405-13. 4. Royal College of Obstetricians and Gynaecologists. Scientific Impact Paper No. 17. The Role of Bariatric Surgery in Improving Reproductive Health. https://www.rcog.org.uk/globalassets/documents/guidelines/scientific-impactpapers/sip_17.pdf Last Accessed on 26th April’ 2016. 5. Dao T, Kuhn J, Ehmer D, Fisher T, McCarty T. Pregnancy outcomes after gastricbypass surgery. Am J Surg 2006; 192(6): 762-6. 6. Wax JR, Cartin A, Wolff R, Lepich S, Pinette MG, Blackstone J. Pregnancy following gastric bypass for morbid obesity: effect of surgery-to-conception interval on maternal and neonatal outcomes. Obes Surg 2008; 18(12): 1517-21. 7. Patel JA, Patel NA, Thomas RL, Nelms JK, Colella JJ. Pregnancy outcomes after laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis 2008; 4(1): 39-45. 8. Bebber FE, Rizzolli J, Casagrande DS, et al. Pregnancy after bariatric surgery: 39
6
pregnancies follow-up in a multidisciplinary team. Obes Surg 2011; 21(10): 154651. 9. Milone M, De Placido G, Musella M, et al. Incidence of Successful Pregnancy After Weight Loss Interventions in Infertile Women: a Systematic Review and Meta-Analysis of the Literature. Obes Surg 2016; 26(2): 443-51. 10. Gosman GG, King WC, Schrope B, et al. Reproductive health of women electing bariatric surgery. Fertil Steril 2010; 94(4): 1426-31. 11. Goldman RH, Missmer SA, Robinson MK, Farland LV, Ginsburg ES. Reproductive Outcomes Differ Following Roux-en-Y Gastric Bypass and Adjustable Gastric Band Compared with Those of an Obese Non-Surgical Group. Obes Surg. 2016 Apr 6. [Epub ahead of print] 12. Graham YN, Mansour D, Small PK, et al. A Survey of Bariatric Surgical and Reproductive Health Professionals' Knowledge and Provision of Contraception to Reproductive-Aged Bariatric Surgical Patients. Obes Surg 2016 Jan 22. [Epub ahead of print] 13. Ginstman C, Frisk J, Ottosson J, Brynhildsen J. Contraceptive Use Before and After Gastric Bypass: a Questionnaire Study. Obes Surg 2015; 25(11): 2066-70. 14. Johansson K, Cnattingius S, Näslund I, et al. Outcomes of pregnancy after bariatric surgery. N Engl J Med 2015; 372(9): 814-24. 15. Kjær MM, Lauenborg J, Breum BM, Nilas L. The risk of adverse pregnancy outcome after bariatric surgery: a nationwide register-based matched cohort study. Am J Obstet Gynecol 2013; 208(6): 464.e1-5.
7
Abbreviations: BOMSS: British Obesity and Metabolic Surgery Society ASMBS: American Society for Metabolic and Bariatric Surgery ACOG: American College of Obstetricians and Gynaecologists RCOG: Royal College of Obstetricians and Gynaecologists
8