Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion
Keywords
Abstract
Description
Today there is an ever-increasing variety of effective contraceptive methods. Although all have side effects, they offer a lower risk than that conferred by pregnancy Contraceptive methods are classified according to their effectiveness. The top tier offer the highest level of effectiveness (defined as Although intrauterine devices (IUDs) are safe, reliable and highly effective forms of long- acting reversible contraception and has a very low failure rate (0.2-0.6 per 100 women per year) , it is used by only 7.6% and 14.5% of contraceptive users in developed and developing countries, respectively According to the latest practice recommendations for contraceptive use by the Centers for Disease Control and Prevention, the potential barriers to IUD use include anticipated insertion pain and health care providers' concerns about difficult insertion ( It is therefore important to identify effective approaches to ease IUD insertion in order to overcome obstacles hindering IUD use Insertion-associated pain is related to speculum insertion, tenaculum traction on the cervix, sounding of the uterus, passing of the insertion tube through the cervix and placement of the device within the uterine cavity Failure of insertion occurs in up to 14% and 20% of parous and nulliparous women, respectively 13). It has been suggested that difficulty and failure of insertion are experienced more in nulliparous women (adjusted odds ratio [AOR] 5.19; 95% confidence interval [CI] 2.49, 10.82) and in those with previous Caesarean delivery (AOR 5.38; 95% CI 2.58, 11.22), due to a narrower cervical os Fouda et al. found that women who had delivered only by Caesarean section experienced more pain with IUD insertion compared with women with previous vaginal delivery Many investigators have studied how to minimize insertion pain or failure. Few studies, however, have assessed any measure to decrease pain or difficulty during IUD insertion in women with previous Caesarean delivery (and no prior vaginal delivery) Pergialiotis et al. conducted a meta-analysis of clinical trials of analgesic options for IUD placement. Owing to the small number of trials, however, they concluded that further studies were needed before a conclusion could be reached Misoprostol is a synthetic analog of prostaglandin E1 originally approved for treatment and prevention of gastric ulcers induced by non steroidal anti inflammatory drugs. It can be administered sublingually, orally, vaginally, or rectally. Vaginal administration has been associated with the highest peak serum levels of misoprostol, and overall bioavailability is greatest for sublingual and vaginal administration. Misoprostol has well-known cervical ripening and uterotonic effects, naturally leading to its use as an adjunct in many gynecologic procedures. Its use has been well studied in the hysteroscopy literature. Multiple well-designed studies have validated the efficacy of different doses of misoprostol before hysteroscopy in reducing pain with dilation, reducing the number of failed dilations, and increasing cervical canal diameter before dilation Given these data, it is reasonable to hypothesize that pretreatment with misoprostol could aid in IUD insertion. As existing studies examining this question have asserted varied conclusions, through this study investigators will evaluate and compare the safety and efficacy of different doses of misoprostol prior to IUCD insertion among women with nulliparous cervix beside the rate of occurrence of adverse effects. This study aims to compare the efficacy and safety of different doses of vaginal misoprostol prior to IUCD insertion among women with nulliparous cervix "those who never delivered vaginally".
Dates
Last Verified: | 06/30/2020 |
First Submitted: | 02/09/2020 |
Estimated Enrollment Submitted: | 02/16/2020 |
First Posted: | 02/17/2020 |
Last Update Submitted: | 07/12/2020 |
Last Update Posted: | 07/13/2020 |
Actual Study Start Date: | 02/29/2020 |
Estimated Primary Completion Date: | 06/14/2020 |
Estimated Study Completion Date: | 06/29/2020 |
Condition or disease
Intervention/treatment
Drug: Misoprostol
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Active Comparator: 1- Group 1 (misoprostol 200 mcg Group 1 :will take 1 tablet (200 mcg) of misoprostol and 1 placebo tablet,
., | |
Active Comparator: 2- Group 2 (misoprostol 100 mcg) Group 2: will take1 tablet (100 mcg) of misoprostol and 1 placebo tablet, | |
Placebo Comparator: 3- Group 3 (placebo group) Group 3 ): will take2 placebo tablets |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | Female |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - Non-pregnant, - Nulliparous cervix: no previous vaginal delivery or any attempt of vaginal delivery, - Seeking for IUD insertion, - Signing an informed consent to participate in the study, Exclusion Criteria: - Pregnancy or signs of pregnancy, - Signs of cervicitis, - Any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids and intrauterine adhesions, - Women with any kind of pelvic pain, - Abnormal uterine bleeding, - History of cervical surgery,• Vaginal delivery, - Contraindication to misoprostol as allergy, - Administration of any analgesics last 12h, - Withdrawal of consent |
Outcome
Primary Outcome Measures
1. Pain scores [during insertion of IUCD]
Secondary Outcome Measures
1. The ease of IUD insertion [during insertion ofIUCD]
2. Successful IUD insertion [5minutes after insertion of IUCD]
3. The duration of insertion in seconds [during insertion ofIUCD]
4. The women's level of satisfaction at the end of insertion [1 miute after insertion of IUCD]
Other Outcome Measures
1. The side effects of the study medication [within 3 hours from inserting the misoprostol tablet]
2. Complications from IUD insertion [during insertion ofIUCD]
3. The number of women who need additional analgesics after the insertion [5 minutes after insertion]
4. Failure of IUD insertion, due to technical difficulty or intolerance of the patient [during IUCD insertion]