scholarly journals Role of suppression of endometriosis with progestins before IVF-ET: a non-inferiority randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eissa Khalifa ◽  
Hashem Mohammad ◽  
Ameer Abdullah ◽  
Mazen Abdel-Rasheed ◽  
Mohammed Khairy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnancy Outcomes ◽  
Ovarian Stimulation ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Cost Of Treatment ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Long Protocol

Abstract Background Endometriosis affects the responsiveness to ovarian stimulation. This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis pursuing IVF treatment. Methods In this randomized controlled trial, 134 women with endometriosis-related infertility were randomly allocated to group A (n = 67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol), and Group B (n = 67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF. The primary outcome measure was the number of oocytes retrieved. The secondary outcome measures included the number of mature oocytes, fertilization rate, quality of life assessed by FertiQoL scores, cost of treatment, and pregnancy outcomes. Results Although there was no statistically significant difference between both groups regarding ovarian stimulation, response parameters, and pregnancy outcomes, the Dienogest group had a lower cost of treatment (2773 vs. 3664 EGP, P < 0.001), lower side effects (29.9% vs. 59.7%, P < 0.001), higher FertiQoL treatment scores (33.2 vs. 25.1, P < 0.001) and higher tolerability scores (14.1 vs. 9.4, P < 0.001 < 0.001). Conclusion Our study indicates that Dienogest is a suitable and safe substitute for GnRHa pretreatment in endometriosis patients. Trial registration NCT04500743 “Retrospectively registered on August 5, 2020”.

scholarly journals Efficacy of a U-Shaped Automatic Electric Toothbrush in Dental Plaque Removal: A Cross-Over Randomized Controlled Trial

2020 ◽  
Vol 17 (13) ◽  
pp. 4649
Author(s):  
Michele Nieri ◽  
Veronica Giuntini ◽  
Umberto Pagliaro ◽  
Monica Giani ◽  
Lorenzo Franchi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Dental Plaque ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Outcome Variable ◽  
Plaque Score ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Electric Toothbrush

Background: The aim of this single-use, four-treatment, four-period (visit), cross-over, mono-centered, examiner-blind, cross-over randomized controlled trial (RCT) was to evaluate the efficacy in dental plaque removal of a U-shaped automatic electric toothbrush (U) compared to a conventional powered toothbrush (P), a habitual toothbrushing procedure (H), and no brushing (N). Methods: Eligible participants were volunteer students. Primary outcome measure was the reduction in full-mouth plaque score (FMPS) after brushing. The secondary outcome variable was a visual analogic scale (VAS) on subjective clean mouth sensation. Mixed models were performed for difference in FMPS and VAS. Results: Twenty-two participants were randomized to the treatments in the four periods of the study. The differences between treatments in FMPS reduction after brushing were statistically significant (p < 0.0001). The differences were statistically significant between the U and P groups (difference −48; 95% CI from −54 to −41) favoring the P group, and between the U and H groups (difference −45; 95% CI from −52 to −39) favoring the H group. On the contrary, the difference between the U and N groups was not significant (difference 5; 95% CI from −2 to 12) favoring the U group. The differences between treatments in clean mouth VAS was statistically significant (p < 0.0001) favoring the P and H groups. Conclusions: The U-shaped automatic electric toothbrush tested in this study proved to be not effective in removing dental plaque.

scholarly journals Randomized Controlled Trial of Probiotic PS128 in Children with Tourette Syndrome

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 3698
Author(s):  
Chang-Chun Wu ◽  
Lee-Chin Wong ◽  
Chia-Jui Hsu ◽  
Chianne-Wen Yang ◽  
Ying-Chieh Tsai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Tourette Syndrome ◽  
Performance Test ◽  
Controlled Trial ◽  
Continuous Performance Test ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Social Environmental

Tourette syndrome results from a complex interaction between social–environmental factors, multiple genetic abnormalities, and neurotransmitter disturbances. This study is a double-blinded, randomized controlled trial using probiotics Lactobacillus plantarum PS128 as an intervention to examine if probiotics improve symptoms of children with Tourette syndrome. This study enrolled children aged 5 to 18 years old who fulfilled DSM-V diagnostic criteria for Tourette syndrome. Patients were assessed before initiating the trial, at one month, and at two months after randomization. The primary outcome was evaluated by Yale Global Tic Severity Scale (YGTSS), and the secondary outcome studied the possible comorbidities in these children. The results revealed no significant difference in improvement in YGTSS between the control group and the PS128 group. As for secondary endpoints, an analysis of Conners’ Continuous Performance Test (CPT) showed improvement in commission and detectability in the PS128 group. In conclusion, although probiotics may not have tic-reducing effects in children with Tourette syndrome, it may have benefits on comorbidities such as attention deficit and hyperactivity disorder (ADHD). Further studies are needed to clarify the effects of probiotics on the comorbidities of Tourette syndrome children.

scholarly journals Radiofrequency Microdebridement as an Adjunct to Arthroscopic Surgical Treatment for Recalcitrant Gluteal Tendinopathy: A Double-Blind, Randomized Controlled Trial

2020 ◽  
Vol 8 (1) ◽  
pp. 232596711989560 ◽  
Author(s):  
Caroline M. Blakey ◽  
John O’Donnell ◽  
Ianiv Klaber ◽  
Parminder Singh ◽  
Manit Arora ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Short Form ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Harris Hip Score ◽  
Secondary Outcome ◽  
Iliotibial Band ◽  
Randomized Controlled ◽  
Gluteal Tendinopathy ◽  
Significant Difference

Background: Recalcitrant greater trochanteric pain is increasingly recognized as an indication for surgical intervention. The arthroscopic approach has become rapidly more common than the open alternative. Hypothesis: Patients undergoing radiofrequency microdebridement (RFMD) as an adjunct to arthroscopic gluteal bursectomy (AGB) and iliotibial band release (ITBR) will experience better functional improvement than AGB and ITBR alone at 1 year. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A total of 33 patients with failed nonoperative treatment of gluteal tendinopathy were randomly allocated to undergo AGB/ITBR or AGB/ITBR + RFMD. Full-thickness tears were excluded. The primary outcome measure was the modified Harris Hip Score (mHHS) at 52 weeks. Secondary outcome measures included the mHHS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analog scale (VAS) for pain, and 12-item Short Form Health Survey (SF-12), which were evaluated at 0, 6, 12, 24, and 52 weeks. Statistical significance was defined as P < .05. Results: A total of 33 participants (33 hips; 30 female and 3 male; mean age, 58 years) were randomized; 16 patients underwent AGB/ITBR + RFMD, and 17 underwent AGB/ITBR. Participants’ functionality improved in both groups at all time intervals. The mean mHHS score improved from 57.49 ± 10.61 to 77.76 ± 18.40 ( P = .004) and from 58.98 ± 12.33 to 79.96 ± 18.86 ( P = .001) at 52 weeks in the AGB/ITBR and AGB/ITBR + RFMD groups, respectively, although there was no statistically significant difference between groups. There were no device-related adverse events. Conclusion: AGB/ITBR led to significant improvements in patients with recalcitrant gluteal tendinopathy. In this small RCT, the addition of RFMD showed no additional benefit to AGB/ITBR but provided a safe adjunct for the surgical management of recalcitrant gluteal tendinopathy. Registration: NCT01562366 ( ClinicalTrials.gov identifier).

Platelet-Rich Plasma for Patellar Tendinopathy: A Randomized Controlled Trial of Leukocyte-Rich PRP or Leukocyte-Poor PRP Versus Saline

2019 ◽  
Vol 47 (7) ◽  
pp. 1654-1661 ◽  
Author(s):  
Alex Scott ◽  
Robert F. LaPrade ◽  
Kimberly G. Harmon ◽  
Giuseppe Filardo ◽  
Elizaveta Kon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Patellar Tendinopathy ◽  
Secondary Outcome ◽  
Global Rating ◽  
Ultrasound Guided ◽  
Randomized Controlled ◽  
Significant Difference

Background: A small number of randomized controlled trials have found ultrasound-guided injection of platelet-rich plasma (PRP) to be no more effective than saline for several tendinopathies; limited information exists for patellar tendinopathy. In addition, different PRP formulations that produce varying concentrations of leukocytes have not been directly compared for patellar tendinopathy. Purpose/Hypothesis: To determine if a single ultrasound-guided PRP injection, either leukocyte-rich PRP (LR-PRP) or leukocyte-poor PRP (LP-PRP), was superior to saline injection for the treatment of patellar tendinopathy. The null hypothesis was that no treatment would be superior to another for the treatment of patellar tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Athletes with patellar tendinopathy for ≥6 months (Blazina stage IIIB) were assessed for eligibility in a multisite single-blind controlled trial. There were 3 injection arms: LR-PRP, LP-PRP, and saline. Patients received a single ultrasound-guided injection, followed by 6 weeks of supervised rehabilitation (heavy slow resistance training, concentric and eccentric, 3 times per week). Outcome measures—Victorian Institute of Sport Assessment (patellar; VISA-P), pain during activity, and global rating of change—were assessed at 6 and 12 weeks and 6 and 12 months. VISA-P score at 12 weeks was the primary outcome. Fifty-seven patients (19 in each group) were included in an intention-to-treat analysis. Secondary outcome measures included pain during activity and patients’ global rating of change. Results: Study retention was 93% at 12 weeks and 79% after 1 year. There was no significant difference in mean change in VISA-P score, pain, or global rating of change among the 3 treatment groups at 12 weeks or any other time point. After 1 year, the mean (SD) outcomes for the LR-PRP, LP-PRP, and saline groups were as follows, respectively: VISA-P—58 (29), 71 (20), and 80 (18); pain—4.0 (2.4), 2.4 (2.3), and 2.0 (1.9); global rating of change—4.7 (1.6), 5.6 (1.0), and 5.7 (1.2) ( P > .05 for all outcomes). Conclusion: Combined with an exercise-based rehabilitation program, a single injection of LR-PRP or LP-PRP was no more effective than saline for the improvement of patellar tendinopathy symptoms. Registration: NCT02116946 (ClinicalTrials.gov identifier).

scholarly journals Step-Down of FSH- Dosage During Ovarian Stimulation – Basic Lessons to Be Learnt From a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Barbara Lawrenz ◽  
Carol Coughlan ◽  
Laura Melado ◽  
Shieryl Digma ◽  
Junard Sibal ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Oocyte Maturation ◽  
Ovarian Stimulation ◽  
Controlled Trial ◽  
Progesterone Level ◽  
Control Group ◽  
Final Oocyte Maturation ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Step Down

A rise in serum progesterone in the late follicular phase is a well described adverse effect of ovarian stimulation for IVF/ICSI. Previous data suggest, that enhanced gonadotropin stimulation causes progesterone elevation and the incidence of premature progesterone elevation can be reduced by declining gonadotropin dosages. This randomized controlled trial (RCT) aimed to achieve a significant reduction of the progesterone level on the day of final oocyte maturation by a daily reduction of 12.5 IU rec-FSH from a follicle size of 14 mm in a GnRH-antagonist protocol. A total of 127 patients had been recruited (Control group (CG): 62 patients; Study group (SG): 65 patients). Due to drop out, data from 108 patients (CG: 55 patients; SG: 53 patients) were included into the analysis. Patients’ basic parameters, gonadotropin (Gn)-starting dose, total Gn-stimulation dosage, the number of retrieved and mature oocytes as well as in the hormonal parameters on the day of trigger (DoT) were not statistically significantly different. However, through stepwise Gn-reduction of 12.5 IU/day in the SG, there was a statistically highly significant difference in the Gn-stimulation dosage on the day of trigger (p &lt; 0.0001) and statistically significant associations for the DoT-P4-levels with the DoT-FSH-levels for both groups (CG: p = 0.001; SG: p = 0.0045). The herein described significant associations between DoT-P4-levels and DoT-FSH-levels confirm the theory that enhanced FSH stimulation is the primary source of progesterone elevation on the day of final oocyte maturation in stimulated IVF/ICSI cycles. Given the pathophysiologic mechanism of progesterone elevation during ovarian stimulation, the use of an increased FSH step-down dosage should be studied in future RCTs, despite the fact that a step-down approach of daily 12.5 IU rec-FSH did not achieve a significantly reduced progesterone level on the DoT.Clinical Trial Registration:clinicaltrials.gov, identifier NCT03356964.

scholarly journals Chyawanprash for the prevention of COVID-19 infection among healthcare workers: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Arun Gupta ◽  
Amit Madan ◽  
Babita Yadav ◽  
Pallavi Mundada ◽  
Richa Singhal ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Healthcare Workers ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Rt Pcr ◽  
Randomized Controlled ◽  
Group I ◽  
Significant Difference ◽  
Group Ii ◽  
Significant Change

AbstractBackgroundCoronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are at high risk of exposure, the standard of care is personal protection from getting infected. Whether Ayurvedic rasayana drug like Chyawanprash can prevent symptomatic infection in frontline health care workers is unknown.ObjectiveTo evaluate the effect of the combination of Chyawanprash and Standard Preventive Regimen compared to the use of Standard Preventive Regimen alone on the proportion of RT-PCR confirmed COVID-19 infections among frontline healthcare workers (HCWs).MethodsAn open-label randomized controlled trial was conducted in the HCWs between 25 to 60 years age currently working in an environment with chance of direct exposure to COVID-19 cases. The interventions to be compared in this trial were Standard Preventive Regimen as per institutional guidelines and based on their roles (Group I) and Ayurvedic Intervention viz., Chyawanprash 12 g twice for 30 days from day of randomization plus Standard Preventive Regimen (Group II). The incidence of RT PCR confirmed COVID-19 cases in both groups, was the primary outcome measure. Evaluation of the safety of the study drug (by any statistically significant change in various biochemical and hematological parameters and occurrence of any adverse drug reactions); incidence of any other infective diseases (bacterial /viral/ fungal / etc.) like upper respiratory tract illness during the study period and any change in the immunoglobulins like IgG, IgM and IgE and inflammatory markers like TNF alpha, IL-6 and IL-10 were the secondary outcome measures.ResultsOut of 193 participants who completed the study, no participant in both groups was COVID-19 positive at the end of one month. In post intervention follow-up, 4 subjects in Group I and 2 subjects in Group II were COVID-19 positive. No adverse drug reaction or any serious adverse event was reported during the study. No clinically significant change in the safety parameters was observed before and after the study. Statistically significant rise in Serum IgG level was seen in Group II but other inflammatory and immune markers did not show statistically significant difference.ConclusionChyawanprash was well tolerated by all the participants in the intervention group but to prove its adaptogenic effect and efficacy as an add-on to the standard care in preventing the occurrence of COVID-19, clinical trial for longer duration with larger sample size is needed.Trial registrationClinical Trials Registry of India vide CTRI/2020/05/025275 dated 20/05/2020Date of IEC approval19.5.2020

scholarly journals Does Capsular Closure Affect Clinical Outcomes in Hip Arthroscopy? A Prospective Randomized Controlled Trial

2021 ◽  
Vol 9 (5) ◽  
pp. 232596712096311
Author(s):  
Etan P. Sugarman ◽  
Michael E. Birns ◽  
Matthew Fishman ◽  
Deepan N. Patel ◽  
Laura Goldsmith ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Outcomes ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Labral Repair ◽  
Harris Hip Score ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Outcome Score ◽  
Significant Difference

Background: There is increasing concern of iatrogenic hip instability after capsulotomy during surgery. Greater emphasis is now being placed on capsular closure during surgery. There are no prospective studies that address whether capsular closure has any effect on outcomes. Purpose/Hypothesis: The purpose of this study was to evaluate patient outcomes after interportal capsulotomy repair compared with no repair. We hypothesized that restoration of normal capsular anatomy with interportal repair will achieve clinical outcomes similar to those for no repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Adult patients with femoral acetabular impingement indicated for hip arthroscopy were randomized into either the capsular repair (CR) or the no repair (NR) groups. All patients underwent standard hip arthroscopy with labral repair with or without CAM/pincer lesion resection. Clinical outcomes were measured via the Hip Outcome Score–Activities of Daily Living (HOS-ADL) subscale, Hip Outcome Score–Sport Specific (HOS-SS) subscale, modified Harris Hip Score (mHHS), visual analog scale for pain, International Hip Outcome Tool, and Veterans RAND 12-Item Health Survey (VR-12). Results: A total of 54 patients (56 hips) were included (26 men and 30 women) with a mean age of 33 years. The HOS-ADL score significantly improved at 2 years in both the NR group (from 68.1 ± 20.5 to 88.6 ± 20.0; P < .001) and the CR group (from 59.2 ± 18.8 to 91.7 ± 12.3; P < .001). The HOS-SS score also significantly improved in both the NR group (from 41.1 ± 25.8 to 84.1 ± 21.9; P < .001) and the CR group (from 32.7 ± 23.7 to 77.7 ± 23.0; P < .001). Improvement was noted for all secondary outcome measures; however, there was no significant difference between the groups at any time point. Between 1 and 2 years, the NR group showed significant worsening on the HOS-ADL (–1.21 ± 5.09 vs 4.28 ± 7.91; P = .044), mHHS (1.08 ± 10.04 vs 10.12 ± 11.76; P = .042), and VR-12 Physical (–2.15 ± 5.52 vs 4.49 ± 7.30; P = .014) subsets compared with the CR group. Conclusion: There was significant improvement in the VR-12 Physical subscale at 2 years postoperatively in the capsular CR group compared with the NR group. Capsular closure appears to have no detrimental effect on functional outcome scores after hip arthroscopy. We recommend restoration of native anatomy if possible when performing hip arthroscopy.

scholarly journals AB0545 COMPARISON BETWEEN METHOTREXATE AND APREMILAST IN PSORIATIC ARTHRITIS-A SINGLE BLINDED RANDOMIZED CONTROLLED TRIAL (APREMEPsA STUDY)

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1305-1306
Author(s):  
J. Samanta ◽  
G. Naidu ◽  
A. Chattopadhyay ◽  
A. Basnet ◽  
T. Narang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Controlled Trial ◽  
Joint Disease ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Significant Difference

Background:Both methotrexate and apremilast were found to be effective in controlling joint disease in psoriatic arthritis (PsA) patients [1-4]. However, there are no head-to-head trials comparing the efficacy of these two drugs in PsA.Objectives:Primary outcome measure was rate of major cDAPSA response (>85% change in cDAPSA score from baseline) at week 24 and secondary outcome measures were ACR 20 response, change in Psoriasis Area and Severity Index (PASI), Maastricht enthesitis score, Leeds dactylitis index, and health assessment questionnaire-disability index (HAQ-DI) and number of adverse events at week 24 between methotrexate and apremilast groups.Methods:Single blinded (physician), parallel group, randomized controlled trial was conducted at a single centre in India between October 2019 and December 2020. Adult PsA patients (age>18 years), fulfilling CASPAR criteria, not receiving methotrexate/apremilast in last 3 months and never receiving bDMARDs or, JAK inhibitors, having active articular disease (one or more swollen joint or, having one or more tender entheseal point) were recruited in this study.Results:A total of 31 patients were recruited (15 in apremilast arm and 16 in methotrexate arm) amongst whom 26 patients completed 24 weeks follow up (13 patients in apremilast arm and 13 patients in methotrexate arm). At baseline, median (IQR) swollen joints were 2 (1) in apremilast group and 2.5 (4) in methotrexate group. Median cDAPSA score at baseline was 23 (9) in apremilast group and 20 (21) in methotrexate group. Major cDAPSA response at week 24 was achieved in three (20%) subjects in apremilast arm and six (37.5%) subjects in methotrexate arm (p=0.433). Seven (46.67%) subjects in apremilast group and nine (56.25%) subjects in methotrexate group achieved ACR 20 response at 24-weeks (p=0.724). The change of PASI score from baseline was significant in apremilast group (2.0, p=0.003) and methotrexate group (0.35, p=0.003), but when compared between the two groups, there was no significant difference(p=0.378). Change in enthesitis score was not significant in both the groups (0.0 in apremilast group, p=0.285; 0.0 in methotrexate group, p=1.0). The median change in dactylitis score [0.0 (9.1), p=0.028] and HAQ-DI score (0.33, p=0.01) were significant in methotrexate group only. However, when compared to the change in apremilast group, the difference was not significant for both the parameters. A total of 9 minor adverse events, 3 with apremilast and 6 with methotrexate, were observed with transaminitis (number of events) being the commonest event noted with methotrexate. There were no serious adverse events noted in either of the groups.Conclusion:There was no significant difference between methotrexate and apremilast in terms of efficacy as measured by cDAPSA and ACR20 responses. Both the drugs were well tolerated by the study population. A larger study with head-to-head comparison between methotrexate and apremilast is needed to conform these findings.References:[1]Baranauskaite A, Raffayová H, Kungurov NV, et al; RESPOND investigators. Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study Ann Rheum Dis. 2012;71:541-8.[2]Mease PJ, Gladman DD, Collier DH, et al. Etanercept and Methotrexate as Monotherapy or in Combination for Psoriatic Arthritis: Primary Results From a Randomized, Controlled Phase III Trial. Arthritis Rheumatol 2019;71:1112-24.[3]Gladman DD, Kavanaugh A, Gómez-Reino JJ, et al. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018;4(1):e000669.[4]Wells AF, Edwards CJ, Kivitz AJ, et al. Apremilast monotherapy in DMARD-naive psoriatic arthritis patients: results of the randomized, placebo-controlled PALACE 4 trial. Rheumatology (Oxford) 2018;57:1253-63.Disclosure of Interests:None declared.

scholarly journals Utility of Gastric Lavage in Vigorous Neonates Delivered with Meconium Stained Liquor: A Randomized Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Jatin Garg ◽  
Rupesh Masand ◽  
Balvir Singh Tomar
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Gastric Lavage ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Group A ◽  
Feed Intolerance ◽  
Group B

Objective. To determine the incidence of feed intolerance in vigorous babies with meconium stained liquor (MSL) who received prophylactic gastric lavage as compared to those who were not subjected to this procedure.Design. Randomized controlled trial.Setting. Tertiary care teaching hospital.Participants/Intervention. 330 vigorous babies delivered with MSL and satisfying the predefined inclusion criteria were randomized either to receive gastric lavage (group A,n=165) or to not receive gastric lavage (group B,n=153). Clinical monitoring was subsequently performed and recorded in prestructured proforma.Results. There was no significant statistical difference (P>0.05) in incidence of feed intolerance in “lavage” and “no lavage” groups.Secondary Outcome. There was no evidence of secondary respiratory distress in either group. None of the patients in the lavage group exhibited adverse effects owing to the procedure.Conclusions. There is no role of prophylactic gastric lavage in neonates born with MSL.

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