Early abortion management at home after 12 weeks is safe and reduces time spent in hospital, study finds

A randomized controlled trial of 435 women undergoing medical abortion after 12 weeks of pregnancy found that 71% of patients who took the first dose of misoprostol at home spent less than 9 hours in hospital, compared with 46% of patients who took the first dose of misoprostol in hospital. No difference in safety was observed between the two groups. However, among women who took the first dose of misoprostol at home, 1% (2/220) completed the abortion before admission to hospital.

In a post-abortion survey, participants in the home group (78%) reported preferring their assigned treatment over the hospital group (49%). The authors say that the ability to take the first dose of misoprostol at home would give women who abort after 12 weeks greater autonomy and reduce the need to stay overnight in the hospital.

Pregnant women who took the first dose of misoprostol (a pill given as part of the medical abortion procedure) at home were 71% more likely to complete their hospital care within 9 hours without staying overnight when they had an abortion after 12 weeks of pregnancy, compared with 46% of those who took the first dose of misoprostol in the hospital, according to a randomized controlled trial published in The Lancet.

Medical abortion (also called abortion by pill) involves taking two types of pills to end a pregnancy: mifepristone, which blocks the hormone progesterone and causes the lining of the uterus to break down, and misoprostol, which causes the uterus to contract. For abortions after 12 weeks of pregnancy, mifepristone is often given in a clinic where the patient returns one to two days later to receive an initial dose of misoprostol followed by additional doses of misoprostol every few hours until the abortion is complete.

In this trial, all patients received the first dose of mifepristone in the clinic as usual, but some patients then took the first dose of misoprostol at home. Previous studies indicate that most medical abortions after 12 weeks of pregnancy are performed within eight to 12 hours of the first dose of misoprostol and require an average of two to three doses of misoprostol, with some patients requiring an overnight stay in hospital.

“Currently, most abortions after 12 weeks of pregnancy take place in hospital and can require an overnight stay, which some women find stressful and isolating. The results of our trial show that taking the first dose of misoprostol at home reduces the average time women spend in hospital, allowing them to leave hospital within nine hours of admission and without spending the night in hospital.

“Offering the choice to take the first dose of misoprostol at home provides a safe and effective alternative to taking all doses of misoprostol in hospital and allows women to manage part of the process themselves, which can lead to a sense of autonomy at a time when women may feel extremely vulnerable,” says author Dr Johanna Rydelius, from Sahlgrenska Academy, University of Gothenburg, Sweden.

She added: “Our study found that 1% of women taking misoprostol at home completed the abortion before going to hospital for the next dose. Previous studies suggest a 1% rate of complete abortion within two hours of the first dose of misoprostol, and women taking misoprostol at home were informed of this risk when they chose to take part in the trial and given a number to call if they had any concerns. It is extremely important that women who have the choice to take the first dose of misoprostol at home are clearly informed of the very small risk of abortion before they go to hospital.”

The study took place in six Swedish hospitals between January 2019 and December 2022. All participants received oral mifepristone tablets in an outpatient clinic and were given one hour to return. Women 12 to 22 weeks pregnant planning to have a medical abortion who chose to participate in the trial were randomized to receive their first dose of misoprostol at home or in hospital.

Women in the home treatment group administered the first dose of misoprostol vaginally at home and returned to the hospital two hours later for the remainder of treatment. Women in the hospital group self-administered the first dose of misoprostol upon arrival at the hospital. All participants then took repeat doses of misoprostol under the tongue every three hours until abortion occurred.

Among patients in the home treatment group, 71% (156/220) spent less than nine hours in hospital, compared with 46% (99/215) in the hospital treatment group. There were no differences in mean pain score, types and number of side effects, or rates of early hospital admission between the two groups. Two patients in the home treatment group (1%) had an abortion on the way to hospital, between one and two hours after taking the first dose of misoprostol.

Patients were asked to complete a follow-up questionnaire two to four weeks after the abortion. Five out of six participants in both trial groups (171/200 of those in the home treatment group and 152/188 of those in the hospital treatment group) reported being very satisfied with the care they received.

When asked, “If you had to choose, where would you prefer to take the first dose of misoprostol?”, 78% of women in the home group and 51% of women in the hospital group said they would prefer to take the first dose of misoprostol at home.

The authors acknowledge some limitations of the study, including that researchers were advised by the data and safety monitoring board to end the trial early due to lower than expected participant numbers and slow progress toward the target of 784 participants. However, feedback from trial sites suggests that the lower than expected participation rate was not due to reluctance to take misoprostol at home, but rather to patients feeling overwhelmed by the overall situation.

“Each patient seeking an abortion faces a unique set of personal and medical circumstances. Choosing to self-administer the first dose of misoprostol at home can provide some patients with a sense of autonomy and comfort during what can be a very trying time in their lives.

“In addition, offering the option to administer the first dose of misoprostol at home would allow more walk-in abortion clinics to offer medical abortions to women more than 12 weeks pregnant, which is particularly important in places where access to abortion care is limited,” says author Professor Kristina Gemzell Danielsson of Karolinska Institutet, Sweden.

In a commentary, Heidi Moseson and Caitlin Gerdts of Ibis Reproductive Health, USA, who were not involved in the study, said: “Improving access to abortion later in pregnancy is a crucial part of the fight for reproductive autonomy; it requires innovation, evidence and a willingness to listen to the needs and experiences of people who seek abortion. Judging by the overwhelming preference for home misoprostol administration in the PRIMA trial, moving toward a less clinically supervised model of medical abortion care later in pregnancy is an important first step.”