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Comparison of the efficacy of two routes of misoprostol administration (sublingual and vaginal) for termination of second trimester pregnancy

Phase 2
Conditions
Pregnancy, childbirth and the puerperium.
-
Registration Number
IRCT138807202576N1
Lead Sponsor
Tehran university of medical university
Brief Summary

AbstractSend to:<br /> Arch Gynecol Obstet. 2013 May;287(5):937-40. doi: 10.1007/s00404-012-2652-4. Epub 2012 Dec 4.<br /> Sublingual versus vaginal misoprostol for cervical ripening before hysteroscopy: a randomized clinical trial.<br /> Tanha FD1, Salimi S, Ghajarzadeh M.<br /> Author information<br /> Abstract<br /> PURPOSE:<br /> To evaluate the efficacy of two routes of misoprostol (sublingual and vaginal) for cervical ripening before hysteroscopy.<br /> METHODS:<br /> One hundred and ten perimenopausal women who were referred to a tertiary hospital for surgical hysteroscopy enrolled in this double-blind randomized clinical trial. They were divided into two groups to receive 400 mg misoprostol either sublingually or vaginally 6 h before hysteroscopy. The duration of dilatation, Hegar number inserted into the cervix without resistance, and hysteroscopic and drug complications were recorded for all cases.<br /> RESULTS:<br /> Forty-nine women in sublingual and 51 in vaginal group participated in the study. Dilatation time was significantly lower in sublingual group (P < 0.001). Median Hegar number passed into the cervix without resistance was 5 in sublingual versus 4 in vaginal group (P = 0.002). Cramp followed by vomiting and diarrhea were the most common side effects of misoprostol in the sublingual group, while cramp followed by vomiting was the most frequent side effect in the vaginal group. Diarrhea was not reported in the vaginal group (P = 0.008).<br /> CONCLUSION:<br /> Sublingual route of misoprostol could be considered as an effective medication before surgical hysteroscopy in perimenopausal women.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
210
Inclusion Criteria

All pregnant women in their second trimester (14-28 weeks) who have been referred to Mirzakoochakkhan hospital for termination of pregnancy; willingness to participate in the study. Exclusion criteria: Allergic reaction to prostaglandin; HTN; Glaucoma; more than twice repeat caesarean section; prolong PPROM; adrenal insufficiency; Parity > 5

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Abortion without surgical intervention. Timepoint: 24 -48hour. Method of measurement: Trans vaginal sonography.
Secondary Outcome Measures
NameTimeMethod
There is no residue of pregnancy. Timepoint: 24-48 h. Method of measurement: Trans vaginal sonography.
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