Early Abortion Less Than Conventional Medication Time Abortion

Initiating early medical abortion was as effective as regular abortion, an international randomized controlled trial found.

An intention-to-treat analysis revealed that complete abortion occurred in 95.2% of participants who started and in 95.3% of those who had a normal period, meaning that there was a significant difference between of the group -0.1% (95% CI -2.4) to 2.1), report Karin Brandell, MD, of the Karolinska Institute in Stockholm, and colleagues New England Journal of Medicine.

Serious adverse events were reported in 1.6% of the initiation group and 0.7% in the standard group (Q=0.10); most of these events were uncomplicated hospitalizations for the treatment of ectopic pregnancy or incomplete abortion. Ectopic pregnancy occurred in 1.3% and 0.8%, respectively, with one rupture before diagnosis in the initial group.

Although medical abortion with mifepristone and misoprostol appears to be safe and effective, there is insufficient evidence regarding its use during pregnancy before pregnancy can be detected by ultrasound. Doctors often delay abortion treatment until a pregnancy can be detected because of concerns that the pregnancy may be ectopic. The American College of Obstetricians and Gynecologists has refused to give specific recommendations for the withdrawal of drugs before pregnancy is confirmed.

“In this trial, as well as in previous diagnostic studies, the early diagnosis of ectopic pregnancy was possible regardless of whether the abortion treatment was started early or late,” the authors wrote. They also noted that screening for early abortion is more important than ever because of the prevalence of abortion restrictions after 6 weeks of pregnancy.

The authors concluded that the results of this trial “demonstrate a non-inferiority in the initiation of abortion medication prior to the confirmation of an intrauterine pregnancy, compared with the standard method of delayed abortion until an intrauterine pregnancy is confirmed.”

Sheila Mody, MD, MPH, of UC San Diego Health, who was not involved in the study, said. MedPage Today that having a randomized controlled trial is a big step since “early studies that looked at premature withdrawal were late.”

“Doctors may not initiate early abortion without such a study showing that early initiation is not inferior to delaying abortion with medication,” he said. said so. Having this evidence is important because “only delaying the onset of abortion creates a barrier to medical abortion” and “many patients seek medical abortion when they first seek it.” abortion care,” Mody said.

This independent, non-inferiority, randomized controlled trial of 1,504 women took place from March 2019 to April 2023 at 26 sites in nine countries: Austria, Australia, Denmark, Finland, Nepal , New Zealand, Norway, Scotland and Sweden. Participants were women 18 years of age and older who spoke English or a local language and were requesting a medical abortion up to 42 days of gestation with an unconfirmed intrauterine pregnancy by ultrasound. feminine. Pathological pregnancy symptoms or signs, risk factors for ectopic pregnancy, and contraindications to medical abortion were exclusion criteria.

Women were assigned to either the initiation group (n=754), which included abortion on the day or day after enrollment, or usual care treatment (n=750), with delay. until an intrauterine pregnancy is confirmed. Serum or plasma chorionic gonadotropin (hCG) was assessed at all pre-abortion visits (except in Nepal, where it was assessed only before intrauterine pregnancy was confirmed). Those whose baseline human hCG level exceeded 5,000 IU per liter were evaluated by a gynecologist for possible ectopic pregnancy.

All participants were given 200 mg mifepristone orally, followed by 800 μg misoprostol administered vaginally, lingually, or buccally 24 to 48 hours later. If bleeding had not started within 3 hours, an additional dose of 400 μg of misoprostol was given (except Australia).

The primary outcome was complete abortion, defined as no ongoing intrauterine pregnancy or need for surgical abortion within 30 days of treatment. Secondary outcomes included incomplete abortion, additional medical treatment, infection treated with antibiotics, unscheduled telephone contact, unscheduled visits, and admission measures including days of with blood and great pain.

Adverse events were defined as complications related to the abortion treatment or attempt and serious adverse events were defined as all conditions resulting in hospitalization for at least 24 hours or bleeding. result in a blood transfusion.

The standard deviation was 3.0 percent for the absolute between-group difference. Baseline characteristics were similar between groups, including mean age (30) and body mass index (25); 34% of women were nulliparous and 44% had a previous abortion.

The authors noted that the trial was not designed to evaluate women with pregnancies of unknown location and those with possible ectopic pregnancies. In addition, women with pathological pregnancies were not followed up for secondary outcomes and there was an imbalance between the groups. They did not collect detailed information on race and ethnicity, which limits the generalizability of the results.

Mody also pointed out that the usual repeat dose of misoprostol is 800 μg, not 400 μg and that in the US, a second hCG is done 24 to 48 hours after misoprostol to see if a decrease of 50% indicating the release of the finished drug. He said that this earlier hCG activity helps nurses quickly determine if the pregnancy was intrauterine rather than ectopic.