Table II Treatment plan and study... | Emerald Publishing

Table II

Treatment plan and study process

Sequence	Procedure and data collection process	Treatment
Admission, day 1
Day 1 at clinic	Vaginal examination (PV) and/or ultrasound exam (if judged necessary) to verify the length of pregnancy and check that pregnancy is intrauterine Medical and gynecological exam, height, weight and blood pressure (BP) according to hospital’s practice Medical, obstetrical and gynecological history taken and recorded	Mf 200 mg orally (1 tablet)
Day 2 or 3 (24–48 h) at clinic or at home	At clinic Brief interview Measurement of BP and pulse rate Physical examination Hourly record of temperature, noting possible side-effects and noting any medication given during the 3-h clinical observation period Recording exact time of expulsion At home Daily record form for bleeding, signs and symptoms after using Ms	Ms 0.8 mg vaginally or sublingually (4 tablets of 0.2 mg)
End of study
Day 10–14 follow-up visit at clinic	Medical and perception interview and review of diary card recorded Pelvic examination Ultrasound examination if judged necessary from clinical findings	If the subject is still bleeding at this visit, she must be examined and a follow-up appointment made

Sequence	Procedure and data collection process	Treatment
Admission, day 1
Day 1 at clinic	Vaginal examination (PV) and/or ultrasound exam (if judged necessary) to verify the length of pregnancy and check that pregnancy is intrauterineMedical and gynecological exam, height, weight and blood pressure (BP) according to hospital’s practiceMedical, obstetrical and gynecological history taken and recorded	Mf 200 mg orally (1 tablet)
Day 2 or 3 (24–48 h) at clinic or at home	At clinic Brief interview Measurement of BP and pulse rate Physical examination Hourly record of temperature, noting possible side-effects and noting any medication given during the 3-h clinical observation period Recording exact time of expulsionAt home Daily record form for bleeding, signs and symptoms after using Ms	Ms 0.8 mg vaginally or sublingually (4 tablets of 0.2 mg)
End of study
Day 10–14 follow-up visit at clinic	Medical and perception interview and review of diary card recorded Pelvic examination Ultrasound examination if judged necessary from clinical findings	If the subject is still bleeding at this visit, she must be examined and a follow-up appointment made

Notes: Mf, mifepristone; Ms, misoprostol; BP, blood pressure