Ligilactobacillus salivarius PS2 Supplementation during Pregnancy and Lactation Prevents Mastitis: A Randomised Controlled Trial

Mastitis is considered one of the main reasons for unwanted breastfeeding cessation. This study aimed to investigate the preventive effect of the probiotic strain Ligilactobacillus salivarius PS2 on the occurrence of mastitis in lactating women. In this multicountry, multicenter, randomized, double-blind, placebo-controlled trial, 328 women were assigned to the probiotic or the placebo group. The intervention started from the 35th week of pregnancy until week 12 post-partum. The primary outcome was the incidence (hazard) rate of mastitis, defined as the presence of at least two of the following symptoms: breast pain, breast erythema, breast engorgement not relieved by breastfeeding, and temperature > 38 °C. The probability of being free of mastitis during the study was higher in the probiotic than in the placebo group (p = 0.022, Kaplan–Meier log rank test) with 9 mastitis cases (6%) vs. 20 mastitis cases (14%), respectively. The hazard ratio of the incidence of mastitis between both study groups was 0.41 (0.190–0.915; p = 0.029), indicating that women in the probiotic group were 58% less likely to experience mastitis. In conclusion, supplementation of L. salivarius PS2 during late pregnancy and early lactation was safe and effective in preventing mastitis, which is one of the main barriers for continuing breastfeeding.

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Topical Pramoxine and Hydrocortisone Foam versus Placebo in Relief of Post Partum Episiotomy Symptoms and Wound Healing

Scottish Medical Journal ◽

10.1177/003693308402900207 ◽

1984 ◽

Vol 29 (2) ◽

pp. 104-106 ◽

Cited By ~ 12

Author(s):

I. A. Greer ◽

A. D. Cameron

Keyword(s):

Wound Healing ◽

Randomised Controlled Trial ◽

Post Partum ◽

Controlled Trial ◽

Hydrocortisone Acetate ◽

Double Blind ◽

Analgesic Consumption ◽

Aqueous Foam ◽

Randomised Controlled

A double-blind randomised controlled trial, comparing pramoxine hydrochloride 1 per cent and hydrocortisone acetate 1 per cent in a mucoadhesive foam base, with simple aqueous foam (B.P.), in relieving episiotomy discomfort and episiotomy healing in 40 patients was carried out. Simple aqueous foam was more effective with regard to wound healing and episiotomy discomfort as measured by analgesic consumption. Pramoxine and hydrocortisone foam offers no advantage over simple aqueous foam in the treatment of post partum episiotomy discomfort.

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Efikasi Misoprostol Rektal Intraoperasi Seksio Cesarea Versus Oksitosin dalam Mengurangi Jumlah Perdarahan untuk Mencegah Perdarahan Post Partum

Jurnal Kesehatan Reproduksi ◽

10.22146/jkr.48773 ◽

2019 ◽

Vol 6 (2) ◽

pp. 37

Author(s):

Milhan Milhan ◽

Ariawan Soejoenoes ◽

Shinta Prawitasari

Keyword(s):

Randomised Controlled Trial ◽

Post Partum ◽

Controlled Trial ◽

Double Blind ◽

Randomised Controlled

Latar Belakang : Perdarahan post partum adalah salah satu etiologi kematian ibu. Setelah operasi caesar, uterotonik dalam bentuk infus oksitosin (20-40 IU) atau misoprostol rektal (200-600 μg) diberikan untuk kontraksi uterus pasca operasi pada pasien pada risiko perdarahan post partum. Penelitian ini dibuat membandingkan kedua agen uterotonik tersebut.Tujuan : Mengetahui perbandingan penggunaan misoprostol rektal tiga tablet (600 ugr) dan penggunaan oksitosin 20 IU selama operasi seksio cesarea dalam mengurangi jumlah perdarahan untuk mencegah perdarahan post partum di fasilitas kesehatan tingkat lanjut.Metode : Penelitian ini adalah double blind randomised controlled trial. Populasi penelitian adalah pasien rawat inap ruang kebidanan dan kandungan RSUD Datu Sanggul, Rantau. Besar sampel ditentukan dengan rumus Kirkwood dan Steme sebesar 98. Secara acak peserta dibagi ke kelompok misoprostol dan oksitosin. Farmasi menyediakan obat penelitian dan plasebo dalam bentuk yang tidak dapat dikenali. Untuk kelompok misoprostol disiapkan tablet misoprostol 600 μg untuk digunakan secara rektal ditambah spuit yang sudah diisi sebelumnya larutan saline normal. Kelompok oksitosin disiapkan tablet plasebo untuk digunakan secara rektal ditambah jarum suntik dengan oksitosin 20 IU dan larutan normal saline.Hasil dan Pembahasan: Didapatkan kelompok 1 (misoprostol) dari 42 sampel, yang mengalami perdarahan kurang dari 1000 ml sebanyak 41 sampel (97,6%) dan yang perdarahan lebih dari atau sama dengan 1000 ml sebanyak 1 sampel (2,38%). Sedangkan kelompok 2 (oksitosin) dari 42 sampel yang mengalami perdarahan kurang dari 1000 ml sebanyak 36 sampel (85,7% ) dan yang perdarahan lebih dari 1000 ml sebanyak 6 sampel (14,3% )Kesimpulan: Ada perbedaan bermakna antara jumlah perdarahan kelompok misoprostol dengan jumlah perdarahan kelompok oksitosin. Karena mean rank kelompok misoprostol lebih rendah dapat disimpulkan bahwa: “Jumlah perdarahan pada penggunaan misoprostol rektal tiga tablet (600 ugr) lebih sedikit dibanding penggunaan oksitosin 20 IU selama operasi seksio cesarea”. Di antara variabel-variabel perancu, riwayat partus lama dan adanya faktor keterlambatan, berhubungan dengan jumlah perdarahan. Variabel yang dapat digunakan untuk memprediksi jumlah atau banyaknya perdarahan adalah variabel “ada terlambat/tidak”. Kata Kunci: Jumlah Perdarahan, Oksitosin, Misoprostol, Perdarahan Postpartum

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Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial

Langenbeck s Archives of Surgery ◽

10.1007/s00423-020-01977-x ◽

2020 ◽

Vol 405 (8) ◽

pp. 1201-1207

Author(s):

Gona Jaafar ◽

Gabriel Sandblom ◽

Lars Lundell ◽

Folke Hammarqvist

Keyword(s):

Antibiotic Prophylaxis ◽

Acute Cholecystitis ◽

Controlled Trial ◽

Study Groups ◽

Double Blind ◽

Randomised Study ◽

Significant Difference ◽

Preoperative Antibiotic Prophylaxis ◽

Randomised Controlled ◽

The Impact

Abstract Purpose Evidence supporting the value of preoperative antibiotic prophylaxis (PAP) in surgery for acute cholecystitis is lacking. This study aimed to shed light on whether PAP in acute cholecystectomy for cholecystitis reduces the postoperative infectious complication (PIC) rate. Secondary outcomes were the prevalence of bacteriobilia, CRP values and leucocyte counts. Methods The study was performed as a single-centre, double-blinded, placebo-controlled, randomised study. Patients with acute cholecystitis amenable for acute laparoscopic cholecystectomy were randomly assigned to either PAP (piperacillin/ tazobactam) or placebo, and the subsequent clinical course was followed. Results A total of 106 patients were enrolled, 16 of whom were excluded due to protocol violation. PIC developed in 22 of the 90 patients included with no significant difference between the PAP and placebo groups (8 patients in the PAP group and 14 in the placebo arm, p = 0.193). The PIC rate was significantly higher in patients with a raised CRP at randomisation and on the day of surgery and in cases of conversion to an open procedure (p = 0.008, 0.004 and 0.017, respectively) but with no differences between the study groups. Conclusion PAP does not affect the risk for PIC in patients with acute cholecystitis. The major risk factors determining PIC in these patients need defining, in particular, the impact of bacteriobilia. Trial registration The study was registered at clinicaltrials.gov (NCT02619149) December 2, 2015.

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Efficacy of maternal B12 supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-034987 ◽

2020 ◽

Vol 10 (5) ◽

pp. e034987

Author(s):

Jitender Nagpal ◽

Manu Raj Mathur ◽

Swapnil Rawat ◽

Deepti Nagrath ◽

Charlotte Lee ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Post Partum ◽

Controlled Trial ◽

Clinical Care ◽

First Trimester ◽

Clinical Trial Registry ◽

Double Blind ◽

Study Results ◽

Randomised Controlled ◽

To Receive

IntroductionVitamin B12 deficiency is widely prevalent across many low- and middle-income countries, especially where the diet is low in animal sources. While many observational studies show associations between B12 deficiency in pregnancy and infant cognitive function (including memory, language and motor skills), evidence from clinical trials is sparse and inconclusive.Methods and analysisThis double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal). Eligible mothers who give written consent will be randomised to receive either 250 mcg methylcobalamin or 50 mcg (quasi control), from enrolment to 6 months post-partum, given as an oral daily capsule. All mothers and their infants will continue to receive standard clinical care. The primary trial outcome is the offspring’s neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants. Secondary outcomes include the infant’s biochemical B12 status at age 9 months and maternal biochemical B12 status in the first and third trimesters. Maternal biochemical B12 status will also be assessed in the first trimester. Modification of association by a priori identified factors will also be explored.Ethical considerations and disseminationThe study protocol has been approved by ethical committees at each study site (India and Nepal) and at University College London, UK. The study results will be disseminated to healthcare professionals and academics globally via conferences, presentations and publications. Researchers at each study site will share results with participants during their follow-up visits.Trial registration numberCTRI/2018/07/015048 (Clinical Trial Registry of India); NCT04083560 (ClinicalTrials.gov)

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OC 8568 A RANDOMISED CONTROLLED TRIAL OF ORAL IRON FOR TREATMENT OF POST-MALARIA ANAEMIA IN MALAWIAN CHILDREN COMPARING IMMEDIATE VERSUS DELAYED ADMINISTRATION

BMJ Global Health ◽

10.1136/bmjgh-2019-edc.34 ◽

2019 ◽

Vol 4 (Suppl 3) ◽

pp. A14.2-A14

Author(s):

Kamija Phiri ◽

Herbert Longwe ◽

Sarah White ◽

Michael Esan ◽

Feiko Ter Kuile ◽

...

Keyword(s):

Placebo Group ◽

Iron Supplementation ◽

Controlled Trial ◽

Secondary Analysis ◽

Group Versus ◽

Double Blind ◽

Iron Administration ◽

Double Blind Clinical Trial ◽

Significant Difference ◽

Randomised Controlled

BackgroundAlthough universal provision of iron supplements to children is recommended by the WHO, it is not yet clear whether the administration of the supplements poses a risk in children in malaria-endemic areas. We investigate the effects of iron supplementation in children with post-malaria anaemia and haematological response with immediate and delayed (2weeks) iron administration.MethodsA randomised double-blind clinical trial was conducted in Zomba and Blantyre between 2009 and 2013. All children aged 4 to 36 months with uncomplicated malaria and with iron deficiency were enrolled into the study. Malaria treatment was administered to all the children and they were randomly assigned to 3 groups as follows: immediate iron administration, delayed iron administration, or placebo. The children were followed up for 10 weeks, with their haematological recovery indices and adverse effects being monitored at 2, 4, 8 and 10 weeks. The primary outcome of the study was the proportion of children without anaemia (defined as Hb >10.9 g/dl) at the end of the iron supplementation period.ResultsA total of 538 participants were randomised to immediate iron administration (n=183), delayed iron administration (n=183), or placebo (n=172). The incidence rate ratio (IRR) of being non-anaemic at the end of the follow-up period (10 weeks post-malaria infection) was 1.51 (95% CI 1.17–1.94, p<0.001) among immediate group versus the placebo group. There was no significant difference between delayed and placebo group (IRR 1.18, 95% CI 0.91–1.55). Secondary analysis of risk of malaria and bacterial infection and iron markers at the end of the intervention period is underway and shall be presented at the conference.ConclusionThe results so far support the administration of iron immediately after completing antimalarial treatment in anaemic children, however safety results will be needed to be reviewed before conclusive recommendations.

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Adjunctive sublingual misoprostol for secondary prevention of post-partum hemorrhage during cesarean delivery: double blind placebo randomized controlled trial

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20180161 ◽

2018 ◽

Vol 7 (2) ◽

pp. 495 ◽

Cited By ~ 1

Author(s):

Hany F. Sallam ◽

Nahla W. Shady

Keyword(s):

Placebo Group ◽

Blood Loss ◽

Secondary Prevention ◽

Cesarean Delivery ◽

Post Partum ◽

Controlled Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Sublingual Misoprostol ◽

Misoprostol Group

Background: Cesarean delivery is the most frequently performed major operative procedure worldwide. Objective of present study was to evaluate randomized evidence regarding efficacy and safety of sublingual misoprostol for secondary prevention of post-partum hemorrhage during and after cesarean delivery in women receiving prophylactic oxytocin as primary preventive tools and bleed around 500ml by visual analogue estimation.Methods: A prospective, randomized, double-blind, placebo-controlled trial was performed at an obstetrics and gynecology department Aswan university hospital, Egypt, between October 2015 and September 2017. Women were eligible if they were undergoing elective cesarean under spinal anesthesia and were bleed around 500ml by visual analogue estimation. All participants received 10 IU oxytocin after delivery of the newborn. Participants were randomly assigned (1:1) to receive 400 μg misoprostol or matched placebo sublingually using a computer-generated random number sequence. Participants and providers were masked to assignment. The primary outcomes were intraoperative and postoperative blood loss.Results: There was high significant reduction in intraoperative blood loss in misoprostol group (711.0±188.41) compared with placebo group (915.33±293.72) (P=0.0001). The all estimated blood loss during CS and 24 hours postoperative was significant lower in misoprostol group (890.39±194.49) than that in placebo group (1096.9±300.05) (p=0.0001).Conclusions: Misoprostol as an adjunct to oxytocin as secondary prevention of pot partum hemorrhage seemed to be more effectively reduce blood loss than did placebo with oxytocin alone.

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Is ovarian relaxin a stimulus to placental protein 14 secretion in pregnancy?

Journal of Endocrinology ◽

10.1677/joe.0.1420375 ◽

1994 ◽

Vol 142 (2) ◽

pp. 375-378 ◽

Cited By ~ 5

Author(s):

H O D Critchley ◽

D L Healy ◽

T Chard

Keyword(s):

Post Partum ◽

Controlled Trial ◽

Late Pregnancy ◽

Serum Levels ◽

Induction Of Labour ◽

Singleton Pregnancy ◽

Double Blind ◽

Placental Protein 14 ◽

Placental Protein ◽

Normal Women

Abstract The objective of this study was to investigate whether relaxin might be involved in placental protein 14 (PP14) secretion by measuring serum levels of PP14 during labour and post partum in normal women with a term pregnancy given vaginal human recombinant relaxin (rhRlx) gel for induction of labour. A randomized double-blind controlled trial was conducted on 11 women with a singleton pregnancy at term admitted for induction of labour. Comparison of serum PP14 and relaxin concentrations in the control and treated groups of subjects revealed that there was an increase in serum relaxin concentrations in women receiving 3 mg or 6 mg relaxin. There was no difference in serum PP14 levels between the control and treatment groups. These findings do not support the hypothesis that relaxin is involved in the control of PP14 secretion. However, the failure of any response might be a consequence of the very small increase in systemic levels of relaxin produced by topical vaginal administration of rhRlx. Furthermore, these measurements were made in late pregnancy and hence may not relate to the events in early pregnancy, when serum levels of PP14 are maximal. Journal of Endocrinology (1994) 142, 375–378

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Vitamin D3 and the risk of CVD in overweight and obese women: a randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114512000098 ◽

2012 ◽

Vol 108 (10) ◽

pp. 1866-1873 ◽

Cited By ~ 35

Author(s):

Amin Salehpour ◽

Farzad Shidfar ◽

Farhad Hosseinpanah ◽

Mohammadreza Vafa ◽

Maryam Razaghi ◽

...

Keyword(s):

Physical Activity ◽

Vitamin D ◽

Placebo Group ◽

Controlled Trial ◽

Hdl Cholesterol ◽

Cholesterol Concentration ◽

Obese Women ◽

Anthropometric Parameters ◽

Double Blind ◽

Randomised Controlled

Evidence indicates that vitamin D deficiency contributes to CVD. We investigated the effect of vitamin D3 supplementation on cardiovascular risk factors in women. Healthy premenopausal overweight and obese women (n 77; mean age 38 (sd 8·1) years) were randomly allocated to the vitamin D (25 μg/d as cholecalciferol) or the placebo group in a double-blind manner for 12 weeks. Blood pressure, serum lipoproteins, apolipoproteins and anthropometric parameters were recorded. Dietary intake was recorded using 24 h food recall and FFQ. Physical activity was assessed by the International Physical Activity Questionnaire. Mean total cholesterol concentrations increased in the vitamin D group (0·08 (sd 0·56) mmol/l) but declined in the placebo group (0·47 (sd 0·58) mmol/l), and a significant effect was observed (P ≤ 0·001). In the vitamin D group, mean HDL-cholesterol concentration increased, whereas it decreased in the placebo group (0·07 (sd 0·2) v. − 0·03 (sd 0·2) mmol/l; P = 0·037). Mean apoA-I concentration increased in the vitamin D group, although it decreased in the placebo group (0·04 (sd 0·39) v. − 0·25 (sd 0·2) g/l; P ≤ 0·001). Mean LDL-cholesterol:apoB-100 ratio augmented in the vitamin D group, while this ratio declined in the placebo group (0·11 (sd 0·6) v. − 0·19 (sd 0·3); P = 0·014). Body fat mass was significantly decreased in the vitamin D group more than the placebo group ( − 2·7 (sd 2) v. − 0·4 (sd 2) kg; P ≤ 0·001). The findings showed that supplementation with vitamin D3 can significantly improve HDL-cholesterol, apoA-I concentrations and LDL-cholesterol:apoB-100 ratio, which remained significant in the multivariate model including anthropometric, dietary and physical activity measures.

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