الفهرس 
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Abstract
The intrauterine contraceptive device (IUCD) is a safe, extremely effective and long acting reversible contraceptive (LARC). It is possible that difficulty in inserting the device limits its use in nulligravidas.
Until a short time ago, the IUCD was indicated only for multiparas this recommendation probably originating from misgivings regarding a possible increase in the incidence of acute PID and the association between this condition and infertility. Although all subsequent studies have confirmed that this risk is low.
In women with previous caesarean section and no prior vaginal delivery, health care personnel may be reluctant to insert an IUCD as this procedure is perceived as risky, with potential complications including failure of insertion and perforation.but recent review confirmed IUCD safety and efficacy in narrow cervical canal as in women who had never delivered vaginally and it is currently considered an ideal contraceptive method for young, nulligravid women.
In an attempt to improve the ease of IUCD insertion. Some investigators tested the use of misoprostol prior to the insertion.
Misoprostol is a prostaglandin E1 analogue approved for the prevention and treatment of gastric ulcers given via different routes (oral, vaginal, sublingual and rectal). It acts on the uterus, causing uterine contractions, cervical dilatation, and an increase in uterine tone via effect on the cellular matrix of the uterine cervix causes dissolution of collagen fibers, increasing the amount of fluid in the stroma and consequently causing cervical effacement.
Aim of the work:
The main objective of this study to evaluate the efficacy of the vaginal misoprostol to facilitate IUCD insertion in women who delivered only by cesarean section.
In order to achieve this objective using stata version 11 programs, the sample size was calculated based on the occurrence of complications following IUCD insertion, two hundred and six women undergoing elective caesarean section and candidate for T Cu 380A IUCD insertion were participated in the study. Half of them were given one suppository 100 mg diclofenac sodium and two tablets ( _ 400 μ g) of misoprostol and the other half was given one suppository 100 mg diclofenac sodium.
This study conducted at Ain-Shams University Maternity in period between February 2016 & July 2016 by a single-blind randomized controlled clinical trial.
Inclusion Criteria:
All women:
- Were between 18 &45 years of age.
- Declared their wish for IUCD placement.
- Gave negative result on pregnancy test.
- Willing maintain attendance during follow-up period for 6-8 weeks for a standard IUCD follow-up visit.
- Had previously delivery by cesarean section.
Exclusion Criteria:
- Active cervical infection.
- Current pregnancy.
- Uterine anomaly.
- Fibroid uterus.
- Copper allergy/Wilson’s disease.
- Undiagnosed abnormal uterine bleeding.
- Cervical or uterine cancer.
- Allergy to misoprostol.
- Previous vaginal delivery.
All women participated in the study were examined before joining to find any exclusion criteria, and Full History: personal, obstetric, menstrual and medical history was taken. Data were collected in a special form for each Participant.
Prior insertion was used of ultrasound to detect uterine position & any Intracavitary pathology and also bimanual examination and sounding of the uterus were necessary to determine the uterine position and the depth of the uterine cavity.
Participants were instructed to administer a numbered, blinded packet with either one suppository 100 mg diclofenac sodium (voltaren ®, Novartis Pharma, Cairo, Egypt) and two tablets ( _ 400 μ g) of misoprostol (Misotac ®, Sigma, SAE, Egypt) or one suppository 100 mg diclofenac sodium (Voltaren ®, Novartis Pharma, Cairo, Egypt) 2hrs before IUCD insertion.
Study outcome measures:
The primary outcome measure of this study was the proportion of failed IUCD insertions, defined as an unsuccessful insertion, regardless of the reason (e.g. immediate expulsion, impossibility to sound the uterus or any resistance were recorded) as well as the degree of difficulty of the IUCD insertion judged as the resistance of the internal cervical os.
Divided the degree of difficulty of the IUCD insertion from represented an extremely easy, easy, moderate, difficult, extremely difficult and failed insertion.
The rate of moderate difficulty and difficult uterine sounding was significantly lower in women of group I [Misoprostol Group] when compared to women of group II [control Group] and recorded that administration of misoprostol prior to IUCD insertion was significantly associated with almost 4-fold reduced risk of moderate/difficult/failed IUCD insertion [RR 0.100 CI (0.048-0.209)]. Administration of misoprostol prior to IUCD insertion was associated with 43.7% reduction in the rate of moderate/difficult/failed IUCD insertion. [ARR43.7%, NNT=4]
The secondary outcome measures were vasovagal-like reactions (dizziness, nausea and vomiting), syncope, partial or total expulsion, heavy bleeding, uterine or cervical perforation, pain during insertion were measured using a visual analog scale (VAS). Graded from 0 to 10. classified into 4 levels:
- No pain (0) - Slight pain (1-3)
- Moderate (4-6) - Severe pain (7-10)
The proportion of women who reported moderate/severe pain during IUCD insertion was significantly lower in women of group I [Misoprostol Group] when compared to women of group II [control Group].
Among the included women, administration of misoprostol prior to IUCD insertion was significantly associated with almost 4-fold reduced risk of moderate/severe pain during insertion [RR0.066 CI (0.025-0.175)]. Administration of misoprostol prior to IUCD insertion was associated with 38.8% reduction in the rate of moderate/severe pain during insertion.
Regarding medication-related side effects, there was a highly significant difference between group I and group II as regard abdominal cramp, as 13.6% of group I cases had cramps compared to 5.8% only of group II cases. However, no significant difference was found as regard other side effects (headache, nausea, vomiting, abdominal cramping, bronchospasm, shivering, fever (temperature ≥38.8°C) and diarrhea) between both groups.
All Participants were seen for a routine check-up one week after IUCD insertion. During this visit, vaginal examination and/or vaginal ultrasound were/was performed. IUCD expulsions and infections were recorded and recorded that no significant difference between group I and group II as regard IUCD site &infection after one week, as 97.8% of group I cases had IUCD in situ compared to 94.5% of group II case had the IUCD in place and regard infection after one week, as 9.8% of group I cases had infection compared to 15.4% of group II case had infection.
So the study shows that using of misoprostol at a dose of 400 microgram administered vaginally 2hrs prior to IUCD insertion in women who delivered by cesarean section increased the ease of insertion and reduced the incidence of pain during the procedure, although the frequency of cramps increased following misoprostol use but vaginally rout less than oral rout.