Literature DB >> 22076561

Clinical trials during pregnancy: what has been done.

Viviana Domínguez1, Nuria Ramos, Abiguei Torrents, David García, Xavier Carné.   

Abstract

OBJECTIVE: We describe clinical trials conducted in pregnant women.
METHODS: We searched PubMed database for articles related to clinical trials between 01/01/2000 and 31/12/2009 involving pregnant women by using the preferred terms "pregnancy", "human", and "clinical trials".
RESULTS: Of 1,264 retrieved publications, 762 (60%) were excluded, leaving 502 for analysis: 53% were preventive studies in maternal or fetal conditions; 47% were therapeutic trials, mostly focused on acute obstetric diseases; 66% were assigned a pharmacological intervention. The studied drugs were 16% for labour induction and 15% for abortive procedures, followed by multivitamins and micronutrients, labour analgesia and anesthesia, antibiotics, tocolytics, and antimalarial drugs. The main objectives of the studies were focused on efficacy (54%) and efficacy and safety (26%); 81% of the studies were controlled, randomized and parallel-design trials; 19% were blinded.
CONCLUSION: Clinical trials in pregnant women are mainly conducted with an efficacy objective regarding maternal-fetal prevention and in obstetric diseases to study labor induction and abortive measures. This is in line with the type of intervention and drugs involved.

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Year:  2011        PMID: 22076561     DOI: 10.1007/s00228-011-1145-x

Source DB:  PubMed          Journal:  Eur J Clin Pharmacol        ISSN: 0031-6970            Impact factor:   2.953


  6 in total

1.  Prescription of drugs during pregnancy in France.

Authors:  I Lacroix; C Damase-Michel; M Lapeyre-Mestre; J L Montastruc
Journal:  Lancet       Date:  2000-11-18       Impact factor: 79.321

2.  Enrolling pregnant women in research--lessons from the H1N1 influenza pandemic.

Authors:  Sara F Goldkind; Leyla Sahin; Beverly Gallauresi
Journal:  N Engl J Med       Date:  2010-06-17       Impact factor: 91.245

3.  Prescribing in pregnancy and lactation.

Authors:  E J Begg
Journal:  Br J Clin Pharmacol       Date:  2008-05       Impact factor: 4.335

4.  Enrolling pregnant women in biomedical research.

Authors:  Ruth Macklin
Journal:  Lancet       Date:  2010-02-20       Impact factor: 79.321

5.  Pharmacotherapy and pregnancy: highlights from the Second International Conference for Individualized Pharmacotherapy in Pregnancy.

Authors:  David M Haas; Mary F Hebert; Offie P Soldin; David A Flockhart; Parvaz Madadi; James J Nocon; Christina D Chambers; Gary D Hankins; Shannon Clark; Katherine L Wisner; Lang Li; Jamie L Renbarger; Lee A Learman
Journal:  Clin Transl Sci       Date:  2009-12       Impact factor: 4.689

Review 6.  Epidemiology of pre-eclampsia and the other hypertensive disorders of pregnancy.

Authors:  Jennifer A Hutcheon; Sarka Lisonkova; K S Joseph
Journal:  Best Pract Res Clin Obstet Gynaecol       Date:  2011-02-18       Impact factor: 5.237

  6 in total
  3 in total

Review 1.  Ethics of studies of drugs in pregnancy.

Authors:  Doreen Matsui
Journal:  Paediatr Drugs       Date:  2015-02       Impact factor: 3.022

2.  Perinatal diet influences health and survival in a mouse model of leukemia.

Authors:  Dushani L Palliyaguru; Annamaria L Rudderow; Alex M Sossong; Kaitlyn N Lewis; Caitlin Younts; Kevin J Pearson; Michel Bernier; Rafael de Cabo
Journal:  Geroscience       Date:  2020-05-11       Impact factor: 7.713

3.  Physiologically Based Modelling of Darunavir/Ritonavir Pharmacokinetics During Pregnancy.

Authors:  Angela Colbers; Rick Greupink; Carlijn Litjens; David Burger; Frans G M Russel
Journal:  Clin Pharmacokinet       Date:  2016-03       Impact factor: 6.447

  3 in total

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