Termination of pregnancy (TOP) Pregnancy and Childbirth Medical abortion
Conditions
Interventions
This trial took place at Ain Shams University Maternity Hospital. The participants will be randomly allocated to the following two groups:
1. Group I: Subjects (n = 24) who will be treated with acidi
Sponsors
Ain Shams University Maternity Hospital (Egypt)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 40 years 2. Missed abortion 3. Singleton pregnancy 4. Gestational age ranging between 14 and 26 weeks of pregnancy (by calculation, examination and/or ultrasound) 5. Uterus and cervix apparently normal on clinical examination 6. Cervix not dilated with absence of effacement 7. Absence of uterine activity 8. Written and signed informed consent by the patient to participate in the study
Exclusion criteria
Exclusion criteria: 1. A contraindication to medical termination of pregnancy, e.g. placenta praevia 2. Evidences suggesting onset of spontaneous abortion (uterine contractions with or without cervical changes) 3. Presence of vaginal bleeding 4. Presence of intrauterine contraceptive device (IUCD) in situ 5. Presence of ruptured membranes and/or suspicion of septic abortion as evidenced by maternal temperature of 38°C or more, uterine tenderness or foul-smelling vaginal discharge 6. Previous trial to induce abortion or the use of pre-induction agent during the current pregnancy 7. Any contraindication to receiving prostaglandins, including known hypersensitivity to misoprostol or other prostaglandins (PGs), history of asthma, glaucoma, cardiac or cardiovascular disease 8. Parity six or more 9. Multifetal pregnancy 10. Polyhydramnios 11. Uterine anomaly, previous two or more caesarean sections, previous uterine surgery, e.g., myomectomy or trauma, e.g., uterine perforation 12. History of any cervical surgery or manipulation: cervical cerclage during current pregnancy history thereof during a previous pregnancy, previous cauterization of cervical erosion, previous cervical dilatation or operation with resultant apparent cervical tears or lacerations 13. Associated collagen or autoimmune medical disorder 14. Metabolic acidosis as a result of a medical disorder 15. History of adverse effects to vaginally administered medications 16. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol which include all vaginal forms of medications 17. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy will be assessed on the basis of improved cervical softening as evidenced by success of induction and its duration. The main outcome measures are 1. Successful abortion rate (defined as expulsion of fetus within 12, 24 and 48 h after administration of misoprsotol) 2. Induction-to-abortion interval (defined as the duration between the application of the first dose of misoprsotol and the time of the expulsion of the fetus) 3. The total dose of misoprsotol used | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Drug tolerability as judged by the investigator will be collected and analyzed 2. Side-effects of misoprostol, including vomiting, diarrhoea, fever (defined as a single temperature reading exceeding 38°C), marked abdominal pain along with the need for analgesic and its total dose 3. Blood loss will be estimated visually by the attending obstetrician and excessive bleeding will be defined as an estimated blood loss of 500 ml or more 4. The rate of incomplete abortion (the need for surgical evacuation of the uterus) | — |
Countries
Egypt
Outcome results
None listed