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The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
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A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
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Randomized Trial of Very Early Medication Abortion.

Karin Brandell1, Tagrid Jar-Allah1, John Reynolds-Wright1

  • 1From the Department of Women's and Children's Health, Division of Obstetrics and Gynecology (K.B., K.G.-D.), and the Department of Clinical Sciences at Danderyd Hospital (H.K.K.), Karolinska Institutet, and the Department of Obstetrics and Gynecology, Karolinska University Hospital (K.G.-D.), Stockholm, Södertälje Hospital, Södertälje (K.B.), the Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg (T.J.-A., H.H.), the Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö (P.T.), the Department of Clinical Sciences, Lund University Faculty of Medicine, Lund (P.T.), the Department of Clinical Sciences, Obstetrics, and Gynecology, Umeå University, Umeå (M.B.), and Statisticon, Uppsala (J.B.) - all in Sweden; the Centre for Reproductive Health, Institute for Regeneration and Repair, University of Edinburgh, and Chalmers Centre, NHS Lothian - both in Edinburgh (J.R.-W., S.C.); the Departments of Obstetrics and Gynecology (F.G., J.K., O.H.) and General Practice and Primary Health Care (F.G.), University of Helsinki and Helsinki University Hospital, Helsinki, and the Division of Health and Social Services, Wellbeing Services County of Vantaa and Kerava, Vantaa (F.G.) - both in Finland; the Center for Research on Environment, Health, and Population Activities, Kathmandu (A.T.), and KIST Medical College Teaching Hospital, Lalitpur (H.T.) - both in Nepal; Family Planning Australia, Sydney Medical School, University of Sydney, and the School of Public Health, University of Technology Sydney - all in Sydney (C.B.); Women's Health, Auckland City Hospital, Auckland, New Zealand (K.S., G.G.); the Department of Obstetrics and Gynecology, Haukeland University Hospital, Bergen, Norway (M.L.); and the Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Hvidovre (M.M.K.), and the Hospital of Southern Jutland, Aabenraa (E.K.) - both in Denmark.

The New England Journal of Medicine
|November 6, 2024
PubMed
Summary

Early medication abortion using mifepristone and misoprostol is as effective as standard treatment. This study shows no significant difference in complete abortion rates for early-onset medication abortion.

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Area of Science:

  • Reproductive Health
  • Clinical Trials
  • Pharmacology

Background:

  • Medication abortion with mifepristone and misoprostol is a safe and effective method.
  • Evidence for efficacy and safety in very early gestations (before ultrasound visualization) is limited.

Purpose of the Study:

  • To compare the efficacy and safety of immediate medication abortion versus standard delayed treatment for unconfirmed early pregnancies.
  • To determine if early-start medication abortion is noninferior to standard care.

Main Methods:

  • A multicenter, noninferiority, randomized controlled trial was conducted.
  • Participants received either immediate medication abortion or standard care after ultrasound confirmation.
  • The primary outcome was complete abortion, with a noninferiority margin of 3.0 percentage points.

Main Results:

  • Complete abortion occurred in 95.2% of the early-start group and 95.3% of the standard group.
  • The absolute difference was -0.1 percentage points, meeting the noninferiority criteria.
  • Ectopic pregnancies and serious adverse events were rare and comparable between groups.

Conclusions:

  • Medication abortion initiated before ultrasound confirmation of intrauterine pregnancy is noninferior to standard delayed treatment.
  • Early-start medication abortion is a safe and effective option for managing early pregnancies.