Mate whenua: follow up after early medical abortion

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: Self‐assessment method of follow up after early medical abortion ‐ using a low sensitivity urine pregnancy test at 3 weeks after taking medications (mifepristone). It takes 1‐2 minutes, can be performed at home, and will be followed up by telephone or text with health practitioner. CONDITION: early medical abortion; ; early medical abortion Reproductive Health and Childbirth ‐ Abortion PRIMARY OUTCOME: Lost to follow up, using audit of patient medical records[6 weeks after early medical abortion (EMA)] INCLUSION CRITERIA: Included are women having an early medical abortion at 10.0 weeks' pregnant or less, who provide informed consent. SECONDARY OUTCOME: Additional community prescription dispensed (categorised as antibiotics, painkillers, or other), audit of patient medical records ; [6 weeks after EMA] Additional health care visit (categorised as to abortion service, hospital emergency department or mental health service), audit of medical patient records ; [6 weeks after EMA] Additional investigations (categorised as blood test, pelvic ultrasound scan, or other), audit of patient medical records ; [6 weeks after EMA] Admission to intensive care unit or equivalent, audit of patient medical records[6 weeks after EMA] Contraception use, assessed by patient questionnaire, developed specifically for this study[12 months after EMA] Death[6 weeks after EMA] ectopic pregnancy (categorised as ruptured or not), audit of patient medical records[6 weeks after EMA] Gestational age in weeks at detection of ongoing pregnancy, audit of patient medical records[8 months after EMA] Haemorrhage, defined as estimated blood loss 500mL or more (categorised as requiring red blood cell transfusion or not), audit of patient medical records ; [6 weeks after EMA] Health care utilisation cost, using the dataset, and basing it on pharmaceutical, equipment and consumable costs, and health care utilisation cost ; [at end of trial] Hospitalisation, audit of patient medical records[6 weeks after EMA] Incomplete abortion/retained pregnancy tissue/retained products of conception, audit of patient medical records[6 weeks after EMA] Incremental cost effective ratio for lost to follow up (LFU) rate, using the dataset[at end of trial] length of stay in intensive care, audit of patient medical records[6 weeks after EMA] number of additional health care visits, audit of patient medical records [6 weeks after EMA] number of additional investigations, audit of medical patient records[6 weeks after EMA] number of additional prescriptions, audit of patient medical records [6 weeks after EMA] Ongoing viable (live) pregnancy, using audit of patient medical records ; [up to 8 months after EMA] outcome of ongoing pregnancy (categorised as live birth, stillbirth, miscarriage, ectopic pregnancy, surgical abortion, medical abortion), audit of patient medical records [8 months after EMA] Patient experience, assessed by questionnaire developed specifically for this study, based on published similar patient experience questionnaires[6 weeks after EMA] Pregnancy outcome (e.g. miscarriage, abortion, birth), assessed by patient questionnaire, developed specifically for this study[12 months after EMA] Pregnancy, assessed by patient questionnaire, developed specifically for this study[12 months after EMA] primary reason for admission to intensive care, audit of patient medical records[6 weeks after EMA] Seen the primary care health practitioner (if yes, main reason), assessed by patient questionnaire developed specifically for this study[12 months after EMA] Staff satisfaction, assessed by questionnaire developed specifically for this study, based on published similar staff satisfaction questionnaires[6 months into recruitment] Successful abortion, defined as termination of pregnancy without need for surgery, audit of patient medical records[6 weeks after EMA] Surgical intervention, audit of patient medical records ; [6 weeks after EMA] timing of follow up test, using audit of patient medical records[6 weeks after EMA] type of additional surgical intervention, audit of medical patient records[6 weeks after EMA] Uterine infection, defined clinically as fever, tachycardia, tender on exam, or purulent vaginal discharge AND received broad spectrum intravenous antibiotics, audit of patient medical records[6 weeks after EMA] Uterine rupture, defined as clinically significant rupture involving the full thickness of the uterine wall and requiring surgical repair, audit of patient medical records[6 weeks after EMA]
Epistemonikos ID: d3d1b90e60ce972113b199077e3f91e4e1b4ea62
First added on: Aug 26, 2024