the symptoms of gastro - oesophageal reflux ( ger ) , heartburn and regurgitation , are common in pregnancy with 4080% suffering at some time during the pregnancy [ 14 ] , and these symptoms can have a marked impact upon quality of life . although the prevalence of ger increases with advancing gestation time , a recent study has shown that the incidence of frequent ger ( women starting with new symptoms ) is consistent across the three trimesters ( about 25% per trimester ) . symptoms often begin in the latter part of the first trimester and persist into the second and then become more frequent and more severe in the third trimester . often , symptoms are particularly prevalent postprandially and at night .   reflux appears to be a normal consequence of pregnancy which resolves postpartum . complications are rare , but two studies now suggest that ger during pregnancy can predispose to ger later and thus may not be so innocuous [ 3 , 5 ] . rey et al .   found that in spain 4.7% of women reported frequent ger symptoms 1 year postpartum compared to 1.3% of matched controls . bor et al .   showed that in turkey heartburn in pregnancy increased the risk of having heartburn 1 year later and that the risk increased with the number of births ( baseline 6.4% , 1 delivery 17.7% , 2 deliveries 36.1% ) . treatment of ger in pregnancy obviously needs to be conservative , and a step - up approach is advocated . initially lifestyle modifications should be promoted ( e.g. , avoiding eating late at night and eating smaller meals ) . when medication is required the first port of call could be alginates or antacids because of their nonsystemic effects . alginate - based reflux suppressants such as liquid gaviscon and gaviscon advance ( reckitt benckiser healthcare ( uk ) ltd ) are licensed for use by pregnant women to combat the frequent symptoms of heartburn and regurgitation . due to the physical mode of action and long - term experience , these products are shown to be safe to use in the high risk pregnancy and lactation population . however , due to the complicated ethical issues relating to evaluating medicines in pregnant women , clinical studies are few and far between and seldom have a placebo - control arm . performed a formal safety and efficacy study using double strength product gaviscon advance ( open label and uncontrolled ) to treat symptoms of heartburn and regurgitation in pregnant women ( n = 146 ) . efficacy of the treatment was deemed very good or good by 90% of the women with symptom relief usually within 10 minutes of taking the medication . frequency and severity of heartburn decreased both in the day and at night after treatment . a few older studies with small numbers have shown efficacy and safety of gaviscon in the treatment of ger in pregnancy . hutt et al .   carried out a drug - monitoring study of 52 women who were pregnant and had taken gaviscon . 98.1% considered the treatment effective , and it was well or satisfactorily tolerated by all women . an italian study by de bellis et al .   evaluated liquid gaviscon suspension in 18 pregnant women during the second and third trimesters . all patients had effective control of symptoms on average within 1015 days of commencing treatment . a french open - label trial   followed 50 pregnant women with reflux in the second and third trimesters treated with gaviscon . all symptoms were significantly improved , including frequency , intensity , and duration of reflux symptoms with 98% positive efficacy . tolerance of the medication was excellent and satisfactorily accepted with no evidence of hypertension or oedema . due to the large number of pregnant users of the alginate - based reflux suppressant liquid gaviscon , there is a need for a robust safety and efficacy study of this product in pregnancy using the uk manufactured formulation that is marketed worldwide . here , we present clinical data from a multicentre open - label study in pregnant women who took the medication for at least 4 weeks with the impact of the medication followed up until delivery of the baby . this was a multicentre , prospective , and open - label study of liquid gaviscon ( lg ) in the treatment of heartburn in pregnant women . there were eight centres involved in the study taken from general practice , hospital antenatal clinics or private clinics of which four were in the uk ( all general practice centres ) and four in south africa ( hospital ante - natal clinics , or private practice clinics ) . pregnant women ( 38 weeks gestation ) between the ages of 18 and 40 with current symptoms of heartburn and/or reflux requiring treatment , as a result of their current pregnancy , were eligible for the study . at the screening visit if the patient had experienced heartburn within the previous 72 hours , they were invited to participate in the study and written informed consent was obtained . treatment was with liquid gaviscon oral suspension ( reckitt benckiser healthcare ( uk ) ltd , hull , uk ) at a dose of 1020  ml as required to relieve symptoms ( prn ) , to a maximum of 80  ml per day , for 4 weeks . treatment was allowed to be continued beyond 4 weeks if wished by the patient and deemed appropriate by the medical team . exclusion criteria for this study were known gastrointestinal ( gi ) disorders , and those with ischaemic heart disease , current uncontrolled clinically significant cns , gi , metabolic , cardiac , hepatic dysfunction , renal dysfunction or systemic disease , or a condition which the investigator thought would compromise patient safety or interfere with efficacy assessment were excluded . with respect to the test product , patients with hypophosphatemia , phenylketonuria or those requiring a low sodium diet were excluded as were those with known sensitivity to any of the ingredients of lg or if the patient was routinely taking the product . there were two study - specific visits ( screening visit and assessment visit at 4 weeks)-but the women were also assessed at each routine antenatal visit , and postpartum . at the study assessment visit study medication use was recorded and frequency and severity of symptoms over the previous 72 hours were detailed . the investigator and patient rated the efficacy of the study medication ( very good , good , acceptable , poor , and very poor ) . any adverse events were recorded along with concurrent conditions , concomitant medication , and the results of blood pressure and blood ( serum potassium and sodium ) and urine tests .   at the postpartum visit , the number of babies delivered was recorded along with gestational age at birth ( premature , full term , and late delivery ) , delivery method , and agpar score ( nominally at 1 and 5 minutes after birth ) . data analysis covered the safety population ( all patients who had received at least one dose of medication ) , intention to treat ( itt ) population ( all patients who had received at least one dose of medication and had recorded efficacy data ) , and efficacy evaluable ( ee ) population ( patients who adhered to the protocol ) . the primary endpoint of investigator assessment of treatment efficacy was summarised as frequency distribution with exact 95% confidence intervals ( ci ) for treatment success rate . the study was conducted in accordance with the declaration of helsinki and the ich note for guidance on good clinical practice . the uk medicines control agency was notified of the study under the clinical trials on marketed products scheme and similarly to the south african medicines control council . this study was conducted using a marketed drug and performed under conditions of the product license . the study recruited 144 patients of which 54 were in the uk and 90 were in south africa . the study assessment visit was attended by 131 patients ( 91% ) , and postpartum data was available for 130 patients ( 90% ) . the safety population comprised 142 patients ( 2 patients never took any medication ) , itt 135 patients , and the ee 97 patients . unless otherwise stated , the mean ( sd ) age of the patients was 28.9 ( 5.4 ) years , and the majority were caucasian ( 71% ) . patients entered into the study on average at 29.1 ( range 1037 ) weeks of gestation with 57% in the third trimester , 42% in the second trimester , and 1 patient in the first trimester . details of their previous pregnancy history are given in table 1 which shows that the majority had had one previous pregnancy that had gone to term . heartburn symptoms had commenced on average at 21.1 ( sd 8.1 , range 436 ) weeks of gestation with the majority starting in the second trimester ( 61% ) and 19% commencing symptoms in both the first and third trimesters . from a total of 627 study and routine antenatal visits , heartburn symptoms had been present in the preceding 72 hours on 93% of occasions . for the itt population the investigator deemed treatment to be a success ( rated good or very good ) in 91% of patients ( 95% ci 85.095.3% ) , and the breakdown of treatment impression similarly , 90% ( 95% ci 84.194.8% ) of patients claimed treatment success with lg with breakdown of responses shown in figure 1(b ) . for the ee population treatment success was seen in 96% of patients ( 95% ci 89.898.9% ) when assessed by the investigator and 95% ( 95% ci 88.498.3% ) when assessed by the patient . interestingly , when symptom frequency and severity were broken down by daytime or nighttime , it was shown that heartburn was classified most often as severe during the night but only moderate during the day in pregnant women . at baseline , 51% of women documented severe or very severe nocturnal heartburn and this a similar extent of improvement was seen with daytime heartburn from 32% experiencing severe or very severe symptoms at baseline to 22% after 4 weeks of treatment . figure 2 indicates how treatment increases the proportion of patients experiencing none or milder symptoms but reduces those at the more severe end of the spectrum . the majority of patients documented relief within 10 minutes of taking the medication ( 67% ) and most within 20 minutes ( 91% ) . patients took a mean ( sd ) of 1.8 ( 1.1 ) doses of lg per day ( range 0.25.5 ) , and the most common dosage volume was 20  ml ( 37% ) . the estimated daily dose per patient was 34.6  ml ( sd 29.7  ml ) . seventy - eight percent of patients continued to use the medication after the 4-week assessment period . the mean ( sd ) time of exposure to lg was 8.8 ( 5.7 ) weeks with the maximum being 25 weeks of use of lg . a total of 130 births were delivered to 129 mothers ( 1 set of twins ) with no data for 17 women . there were three intrauterine deaths ( still births ) , and 1 baby ( born prematurely ) died after the post - partum visit that all occurred in south africa . the majority of births ( 95% ) were delivered between 36 and 44 weeks with 5% premature . apgar scores recorded after a median time of 1 minute ranged from 2 and 10 ( mode 9 ) and was 7 in 92% of babies . the apgar scores recorded a median of 5 minutes ranged from 6 and 10 ( mode 10 ) and was 7 in 95% of babies . serum potassium and sodium levels were monitored because of the sodium load of the product and the potential impact upon blood pressure or fluid retention in the pregnant population . at baseline , mmol / l and at the study assessment visit values were similar with mean ( sd ) 137.8 ( 2.78 ) serum potassium levels did not change throughout the study with mean ( sd ) serum potassium 4.0 ( 0.37 ) there were no patients with clinically significant deviations in serum electrolytes from the reference range . overall , 86 patients reported 237 emergent adverse events during the study ( table 2 ) and were most commonly female reproductive system disorders ( 29% ) , gi system disorders ( 16% ) , or general disorders ( 9% ) . most adverse events reported by the mothers were disorders caused or aggravated by pregnancy ( e.g. , caesarean section , hypertension , and anaemia ) . only 27 events ( 21 patients ) were considered of severe intensity and only 3 events were considered possibly or probably related to the study medication , and these were single occurrences of hypertension , diarrhoea , and nausea which lead to withdrawal of these 3 patients from the study . serious adverse events were experienced by 27 patients reporting 47 events . in 16 of these serious adverse events , caesarean section was classified as an adverse event , but all had an additional adverse event associated with the caesarean section . there were 18 adverse events ( predominantly fetal distress ) reported for 17 fetuses ( table 2 ) , and although 7 events ( 6 fetuses ) were deemed severe , none of the events experienced by the fetuses were considered to be possibly or probably related to the study medication . there were 14 serious adverse events from 13 fetuses and there were 3 intra - uterine deaths ( 2 episodes of placental abruption and one due to intrapartum asphyxia ) , but none of these serious events were considered related to the study medication . in 19 babies , 27 events were reported ( table 2 ) and 4 events ( 3 babies ) were severe , but none were considered possibly or probably related to the study medication . there were 6 serious adverse events ( 5 neonates ) with one neonatal death as a result of a premature delivery ( 31.5 weeks gestation ) and respiratory disorders ( hyaline membrane disease and bronchopleural fistula ) . however , none of the serious adverse events were considered possibly or probably related to the study medication . very few adverse events or serious adverse events were reported for mothers in the study that were considered to be related to the medication . adverse events and fetal / neonatal deaths were consistent with the population incidences in the uk and south africa ( table 3 ) and indicated no safety concerns for lg use during pregnancy . it should be noted that the infant mortality rate ( perinatal and neonatal ) in south africa is variable depending on the socioeconomic status [ 22 , 23 ] . caesarean section rates are high in south africa , but as the study group consisted of some private clinics , the rate of caesarean section is estimated to be 30% . the prevalence of heartburn during pregnancy is high , and treatment needs to be safe to both the mother and unborn child . lg has a non - systemic mode of action by forming an alginate raft on the stomach contents to physically prevent reflux into the oesophagus . its mode of action should not pose any safety concerns to the mother or child , nor should the mode of action be affected by physiological changes seen in pregnancy . therefore , despite its extensive use throughout pregnancy , there was a requirement to undertake a formal safety study . this prospective clinical study evaluated the safety and efficacy of lg for the treatment of heartburn in pregnancy in an open - label format . this study used a standard real - life dosage regimen in that patients could take medication as required ( up to a maximum of 80  ml per day ) . although the formal efficacy study lasted for 4 weeks , the protocol allowed patients to continue treatment if desired ( of which the majority did ) , thus this more accurately reflected normal clinical practice and allowed assessment of longer term safety of the medication rather than a fixed short - term study . the efficacy of lg in the treatment of heartburn in pregnancy was assessed by both investigator and patient at 4 weeks . treatment success ( good or very good response ) was seen in 91% of patients as judged by the investigator and 90% from self - appraisal . this shows that lg is highly efficacious in this population and equivalent to patient perception of treatment with gaviscon in pregnant women in the retrospective studies by hutt et al . data was comparable to the use of gaviscon advance in pregnant women ( 88% )   and gaviscon advance in the normal population ( 84% ) . when symptom frequency and severity were broken down , it showed that heartburn was classified most often as severe during the night but only moderate during the day in pregnant women . since nocturnal symptoms are particularly important to the quality of life of pregnant women , this improvement in symptoms with lg treatment is a positive outcome . there were no safety concerns identified from this study which evaluated lg use by pregnant women . although the formal efficacy study was carried out over 4 weeks , the protocol allowed women to continue lg use through pregnancy if they wished , and thus the safety study was carried out with long - term real - life use . the study was carried out in the uk and south africa , and adverse events for the mother , fetus , and baby were consistent with the population norms for those countries . crucially , there were no disturbances in serum sodium levels as a result of the sodium load of the product . this is important in pregnant women as hypertension , preeclampsia , and oedema are important complications in pregnancy , so there were no safety concerns of lg in that respect . lg is licensed for use in pregnancy to treat heartburn and reflux symptoms that are common in this population , although transient can have a large impact in quality of life . treatment should first take the form of diet and lifestyle advice followed by non - systemic therapy ( antacids or alginate suspensions ) . the efficacy and the safety of alginate suspension in pregnancy have been established in this study and also previously   such that , when lifestyle improvements do not help , alginates may be the first treatment choice in this sensitive population . however , randomised controlled trials are advocated to strengthen the evidence regarding the efficacy and safety of lg . this prospective open - label study in a large number of pregnant women in the uk and south africa suggests that liquid gaviscon , 1020  ml as required , is both safe and highly efficacious in the treatment of heartburn and ger symptoms that are prevalent and bothersome throughout pregnancy . there were no safety concerns of liquid gaviscon use for the mother or unborn child , and importantly there were no concerns regarding serum sodium levels .
gastro - oesophageal reflux ( ger ) and the symptoms of heartburn and regurgitation are common in pregnancy . these symptoms are transient and mostly resolve postpartum but have a negative impact on quality of life . here 
 , we present a prospective clinical evaluation of the safety and efficacy of an alginate raft - forming oral suspension that is licensed for use in pregnancy . 
 the study was a multicentre , prospective , open - label , and baseline - controlled study of liquid gaviscon ( lg ) in the treatment of heartburn in pregnant women with current symptoms of heartburn and/or reflux requiring treatment ( recruited 144 ) . 
 the efficacy of the study medication was rated by the investigator ( primary endpoint ) and patient . 
 treatment was deemed to be a success in 91% of patients as judged by the investigator ( 95% ci 85.095.3 ) and 90% ( 95% ci 84.194.8 ) when assessed by the patient themselves . 
 very few adverse events or serious adverse events were reported that were considered to be related to the study medication , and these were consistent with the normal population incidences . 
 serum sodium levels remained unchanged . 
 this prospective open - label study in a large number of pregnant women has shown that lg is both safe and highly efficacious in the treatment of heartburn and ger symptoms in pregnancy .