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Abortion in First Trimester clinical trials

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NCT ID: NCT05341817 Recruiting - Clinical trials for Abortion in First Trimester

The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy

Start date: November 22, 2022
Phase: Phase 4
Study type: Interventional

Medical termination of pregnancy (mTOP) generally involves using either a combined regimen consisting of mifepristone and misoprostol, or a misoprostol-only regimen. Complete abortion rates of first trimester mTOP with the use of misoprostol-only regimen varies between 74-88%. With the addition of mifepristone as pre-treatment drug, this improves success rates to 93-97%. Mifepristone, an anti-progesterone, is relatively expensive and is subject to stringent regulations for usage in addition to restricted access in many countries. Therefore, there is a need to find a cheaper and more readily available, yet effective alternative. The use of letrozole (an aromatase inhibitor) in mTOP is postulated to suppress estradiol levels (an important factor in the maintenance of early pregnancy), therefore enhancing the effect of misoprostol in inducing abortion. Studies have shown that pre-treatment with letrozole achieves a complete abortion rate of 77-98%, similar to that in mifepristone-Misoprostol studies. The investigators hypothesise that letrozole is equivalent to mifepristone for the pre-treatment of mTOP and propose to conduct a randomised, non-inferiority trial for mTOP up to 10 weeks gestation with two arms as detailed below: 1. Oral letrozole 10mg daily for 3 days, followed by vaginal misoprostol on Day 3 (Intervention group) 2. Oral mifepristone 200mg once on Day 1, followed by vaginal misoprostol 800mcg on Day 3. Then, 4 hours later, another dose of 400mcg PV misoprostol if no signs of abortion (Control group - current practice). The investigators aim to include a total of 144 patients, 72 in each arm, to detect a non-inferiority margin of 15% with a power of 80% at 5% significance. The investigators primary outcome will be rate of complete abortion by Day 21-28 of mTOP. This pilot RCT will provide preliminary data and preparation for larger grant application which will provide necessary evidence to enhance the care of women undergoing mTOP, with enhanced cost-savings and availability.

NCT ID: NCT05182008 Recruiting - Clinical trials for Abortion in First Trimester

A Patient Decision Aid for Method of Early Abortion: A Randomized Control Trial

Start date: May 5, 2022
Phase: N/A
Study type: Interventional

Introduction: There are two options for women seeking early pregnancy termination in Canada; either surgical or medication abortion. When making a decision about which option is best for them, patient must consider their values as well as social resources and circumstances Patient decision aids (PtDAs) are tools to help patients make health-related decisions, particularly when no 'best' choice exist. Our research team has developed an online interactive patient decision aid on method of abortion based on international standards for decision aid development. We would like to investigate whether it leads to improved decisional quality in patients seeking early abortion. Methods: Phase 1 will be development of an abortion knowledge assessment tool. We will start by developing ten multiple choice questions based on information that is classically included in abortion education material. The goal is to ultimately include 5-7 well-performing questions in the trial. The ten questions will be sent to content experts to answer and rate. They will rate the questions on representativeness and importance. The questions will also be administered to community members without specific abortion knowledge. Results will be used to assess content validity and discriminator validity and revise the questionnaire. Phase 2 will be a randomized trial of people seeking abortion at less than 63 days gestation. Those who wish to participate will be randomized either the decision aid (study group) or the standard abortion clinic website (control). They will then be asked to participate in a survey immediately after they are finished reviewing the decision aid or website to. This survey will include questions about their decision, demographics, medical history, and their level of knowledge about abortion methods (by administering the knowledge assessment tool described above). The evaluation of the decision making will be measured using the Decisional Conflict Score. Four weeks post procedure, participants will be contacted by e-mail again and asked to complete a second survey identifying which type of abortion they underwent along with an inventory of perceived adverse treatment effects, as well as completing a Satisfaction with Decision Scale (SWD)

NCT ID: NCT04956731 Recruiting - Clinical trials for Abortion in First Trimester

Pharmacist Provision of Medication Abortion

Start date: January 12, 2022
Phase: N/A
Study type: Interventional

This will be a pilot study among two pharmacists providing start to finish medication abortions to 10 patients utilizing a previously created toolkit. Following completion of the pilot, we will perform in-depth semi-structured interviews with the participating patients and pharmacists to understand their experiences with pharmacist provision of medication abortion. In addition, we will elicit feedback about ways to refine the toolkit to support the scale-up of pharmacist provision of medication abortion in the future.

NCT ID: NCT04336358 Recruiting - Clinical trials for Abortion in First Trimester

Telemedicine for First Trimester Abortion in South Africa

Start date: February 27, 2020
Phase: N/A
Study type: Interventional

The study aim to determine if medical abortion facilitated by a physician online (s.c. telemedicine), combined with a simplified physical exam, is equally effective, safe and acceptable to women in South Africa as standard medical abortion care.