‘pregnancy’ Tagged Posts

Micro Vitamins in Being pregnant / IRON CALCIUM | கர்ப்ப கால ஊட்டச்சத்து குறித்த விளக்கம் | Dr. Sredevi

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Viagra in being pregnant trial stopped after 11 new child infants died

 

A Dutch clinical trial was looking at the potential of Sildenafil or impotence drug Viagra to improve the growth in unborn babies of pregnant women. The study had to be stopped prematurely after the death of eleven babies.

Sildenafil is capable of improving the blood flow. In the clinical trial the team of researchers tried to use the drug to improve the blood flow to the placenta of the pregnant women. These participating pregnant women had poorly developed placenta that caused retardation of overall growth in the fetus. However when administered with Viagra the babies died because the drug causes fatal damage to the lungs of these unborn babies. A detailed investigation is underway to examine the cause of the deaths. Meanwhile authorities have stated that there has been no wrong doing in the trials.

There have been earlier smaller clinical trials in Australia, New Zealand and UK where Viagra had been administered to pregnant women with poorly developed placenta and fetal growth retardation. No harm was seen to the participating mothers in those studies. However Viagra failed to provide any extra benefits in these mothers. Thus in 2010 it was felt that the drug in these scenarios should be used only in clinical trials.

At present there are no treatments for fetal growth retardation due to poorly developed placenta in the mother. These babies are usually born prematurely and have a low birth weight. They have a poor chance of survival. This trial was an attempt to develop a medication that could prolong the gestational period till the baby is well grown and increase the body weight of the baby. This medication could save lives, felt the researchers.

For this study the Dutch researchers included participants who would be recruited for the study up until 2020 and the study would be carried out in 11 hospitals in the Netherlands, one of which is the Amsterdam University Medical Centre. The study began in 2015 and a speculated 350 patients were to be recruited. For this phase of the study 93 women were included and they were all administered Sildenafil. Another 90 women were included in the trial as controls and they were given a placebo drug or dummy.
After delivery it was noted that twenty babies developed lung complications. Of these three were in the placebo group and 17 were from the Sildenafil treated group. Eleven of the sick babies in the sildenafil group died of the lung complications. Eight other babies in the sildenafil treated group died of unrelated complications. Of the three babies in the placebo group that developed lung complications, none succumbed to the illness. Nine babies in the placebo group died due to unrelated causes. An independent committee looked at the study outcome and last week the study was terminated prematurely.

Prof Zarcko Alfirevic, from the University of Liverpool, was part of the UK team. He said that this result from the Dutch study is “unexpected” and more is to be found on the underlying mechanism of the deaths in the babies. “It needs a thorough investigation because the complications were not seen in the two other, similar trials that have already been done in the UK and Australia and New Zealand,” he said.

Wessel Ganzevoort, lead researcher and a gynaecologist said that the last thing they wanted is to harm the patients and they are shocked with the results. He said that their team has informed Canadian researchers who are conducting a similar study and instructed them to stop their research.

Source:

https://www.amc.nl/web/nieuws-en-verhalen/actueel/actueel/onderzoek-gestaakt-met-medicijn-tegen-groeivertraging-ongeboren-baby-.htm

Posted in: Drug Trial News

Tags: Baby, Birth Weight, Blood, Clinical Trial, Impotence, Lungs, Newborn, Placebo, Placenta, Pregnancy, Research

Preventive therapy for recurrent being pregnant loss proved ineffective in giant examine

 

An immune response to being pregnant (by which the uterus rejects the embryo or fetus) is alleged to elucidate a lot of in any other case “unexplained” miscarriages. Thus, preventive therapy designed to suppress this immunological rejection throughout implantation and being pregnant has grow to be a generally accepted – albeit modern – strategy to stopping recurrent being pregnant loss. A variety of “immunomodulatory” remedies are provided, most of that are non-evidence primarily based and the most recent of which is a drug generally known as recombinant human granulocyte-colony stimulating issue (rhG-CSF), a regulator of neutrophils and different lymphocytes activating and defending the immune system. That is extensively used (and licensed) in most cancers medication to extend white blood cells after chemotherapy.

Now, a big randomized placebo-controlled examine – the most important of its form, the RESPONSE trial – described right here in the present day on the 34th Annual Assembly of ESHRE has discovered no proof that rhG-CSF given within the first trimester of being pregnant improves outcomes in girls with a historical past of unexplained recurrent being pregnant losses. The outcomes are offered by honorary analysis fellow Dr Abey Eapen from Tommy’s Nationwide Centre for Miscarriage Analysis on the College of Birmingham, UK, and the College of Iowa Hospital and Clinics, USA. The examine, a managed randomized trial involving 150 girls with a historical past of unexplained miscarriage, was carried out at 21 hospitals within the UK.

As background to the examine, Eapen mentioned that proof in favor of rhG-CSF within the prevention of recurrent being pregnant loss was primarily based on only one single-center randomized trial and 4 additional observational research, which all prompt a statistically vital improve in being pregnant and stay beginning charges within the therapy teams.

On this examine, with an endpoint outlined as medical being pregnant charge at 20 weeks gestation, 76 girls had been randomised to rhG-CSF and 74 to placebo. All topics had had at the least three unexplained miscarriages, had been aged between 18 and 37 years, and had been making an attempt to conceive naturally.

At follow-up, outcomes confirmed a medical being pregnant charge at 20 weeks of 59.2% within the rhG-CSF group, and of 64.9% within the placebo group, suggesting a impartial impact of the therapy. With additional follow-up, these charges had been equally evident in stay beginning.

“Worldwide, granulocyte-colony stimulating issue is extensively utilized in reproductive medication to deal with pregnancies conceived each naturally and after assisted replica following recurrent miscarriages,” mentioned Eapen. “Some research have prompt statistically vital enhancements in medical being pregnant charges, however we right here have top quality proof that rhG-CSF is just not an efficient therapy for sufferers with unexplained recurrent miscarriages.”

Miscarriage – whether or not recurrent or not – is a standard and distressing complication of being pregnant, particularly in IVF when a lot emotion and energy has been invested in therapy. Estimates are that round 1-2% of all expertise recurrent being pregnant loss, however Eapen mentioned that it’s troublesome of estimate the precise numbers utilizing rhG-CSF. “It is a comparatively new therapy and is obtainable primarily by personal miscarriage and IVF clinics.”

He additionally described reproductive immunology is a “comparatively new and younger” department of reproductive medication. “We first have to agree on an appropriate definition primarily based on dependable and reproducible laboratory investigations earlier than labeling a miscarriages as immune-mediated,” he mentioned. “Most of immunotherapy drugs examined thus far by high-quality trials have been proven to supply no profit. Ladies recognized with recurrent miscarriages are weak, so it is essential that, in the event that they’re given immune modulatory therapy for recurrent miscarriages, they’re recommended about success charges and potential danger/advantages, even in a analysis setting, not to mention routine medical observe.”

Even after a analysis of recurrent miscarriage, the vast majority of pregnancies do have a positive consequence. “However,” mentioned Eapen, “it’s nonetheless essential that these girls are investigated and managed in a specialist miscarriage clinic for counseling, assist, evidence-based investigation, and a possibility to participate in analysis. Nutritious diet and administration of modifiable danger components might also assist.”

Supply:

https://www.eshre.eu

Antifungal Use Throughout Being pregnant and Danger of Stillbirth: What is the Hyperlink?

 

June 13, 2018

Oral antifungal use during pregnancy is generally not recommended but data has shown 0.5 to 4% of pregnant women still receive this treatment.

Oral antifungal use throughout being pregnant is usually not really useful however knowledge has proven zero.5 to four% of pregnant girls nonetheless obtain this therapy.

Utilizing oral fluconazole throughout being pregnant was not tied to the next threat of stillbirth, in line with a examine revealed in JAMA.

Oral antifungal use throughout being pregnant is usually not really useful however knowledge has proven zero.5 to four% of pregnant girls nonetheless obtain this therapy. Researchers from the Karolinska Institute beforehand discovered that fluconazole use throughout being pregnant was tied to an elevated threat of spontaneous abortion and attainable stillbirth. 

“There are considerations based mostly on animal knowledge that oral fluconazole use in being pregnant could result in fetal loss of life. Given this concern and the paucity of research in people, we wished to analyze the problem additional,” defined lead writer Björn Pasternak, MD, PhD, affiliate professor at Karolinska Institute’s Division of Medication in Solna.

For this examine, Pasternak and colleagues aimed to establish whether or not any fluconazole use throughout being pregnant was related to stillbirth (fetal loss after 22 accomplished weeks) and neonatal loss of life (zero to 27 days after stay beginning). A complete of 10,669 girls from the nationwide Swedish and Norwegian register database have been in comparison with 106,387 girls who didn’t use fluconazole; baseline traits have been comparable between each teams. 

Amongst fluconazole-exposed pregnancies, there have been 2.7 stillbirths per 1000 in contrast with three.6 stillbirths per 1000 amongst unexposed pregnancies (hazard ratio [HR] zero.76, 95% CI, zero.52-1.10). There have been 1.2 neonatal deaths per 1000 uncovered pregnancies and 1.7 neonatal deaths per 1000 unexposed pregnancies (threat ratio [RR] zero.73, 95% CI, zero.42-1.29). 

The info have been comparable for fluconazole doses that have been ≤300mg or >300mg. Extra analyses in line with different covariates confirmed constant outcomes with the first analyses.

Based mostly on the findings, it was concluded that fluconazole use throughout being pregnant was not related to considerably elevated dangers of stillbirth or neonatal loss of life. Nonetheless, the authors cautioned that the boldness intervals have been broad and neither end result was statistically important. 

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“Though the info on fluconazole use in being pregnant recommend no elevated threat of stillbirth, further research needs to be carried out and the collective physique of knowledge scrutinized by drug authorities earlier than advice to information scientific determination making are made, and weighed in opposition to the advantages of remedy,” Dr. Pasternak concluded

For extra info go to jamanetwork.com.

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CDC Recommends Further Malaria Tx Choice Throughout Being pregnant

 

April 12, 2018

Artemether-lumefantrine was approved in 2009 by the Food and Drug Administration

Artemether-lumefantrine was permitted in 2009 by the Meals and Drug Administration

The Facilities for Illness Management and Prevention (CDC) has issued up to date suggestions on the therapy of  malaria in pregnant sufferers in the US. 

The CDC now recommends using artemether-lumefantrine (Coartem; Novartis) as an extra therapy possibility for uncomplicated malaria in pregnant ladies throughout the second and third trimester of being pregnant on the identical doses really useful for nonpregnant ladies. Throughout the first trimester of being pregnant, mefloquine or quinine plus clindamycin ought to be used as therapy, nevertheless when neither of those choices is offered, artemether-lumefantrine ought to be thought of.

Artemether-lumefantrine was permitted in 2009 by the Meals and Drug Administration (FDA) to deal with uncomplicated malaria nevertheless, the mixture therapy was not permitted to be used in being pregnant as a result of animal information indicating poor outcomes.

To evaluate the security and efficacy of artemisinin-based mixture therapies (ACTs) throughout being pregnant, researchers from the CDC carried out an evaluation of the literature which included medical trials, observational research, meta-analyses and case reviews carried out in Asia and Africa. In complete, 21 articles have been analyzed. 

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An evaluation of 5 randomized, open-label, managed trials carried out in Uganda and Thailand with ladies administered ACTs throughout their second and third trimester for uncomplicated P. falciparum malaria discovered that the treatment charges have been ≥94.9%. Moreover, statistically related therapy failure charges have been famous in a meta-analysis of 6 trials involving ladies taking ACTs vs non-ACTs to deal with uncomplicated malaria (RR=zero.41; 95% CI=zero.16-1.06). The findings additionally indicated that doses really useful for nonpregnant ladies have been efficacious throughout being pregnant.

Concerning security, no variations in outcomes have been present in four trials evaluating ACTs with quinine-based regimens. General, the researchers discovered that fewer maternal hostile occasions occurred amongst ladies taking ACTs than in these taking non-ACTs. Three trials evaluating artemether-lumefantrine with different ACTs discovered no distinction in charges of great hostile maternal results.

The CDC’s choice follows an analogous one from the World Well being Group, which just lately endorsed ACTs for therapy of uncomplicated malaria throughout the second and third trimester.

For extra info go to CDC.gov.

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