Vaginal application of acetic acid 3% gel to hasten induction of abortion in women with mid-trimestric missed abortio

Completed

• Conditions: Termination of pregnancy (TOP); Pregnancy and Childbirth; Medical abortion

• Registration Number: ISRCTN75746444
• Lead Sponsor: Ain Shams University Maternity Hospital (Egypt)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 48

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified