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ORIGINAL ARTICLE |
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Year : 2022 | Volume
: 35
| Issue : 1 | Page : 240-244 |
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Role of vaginal misoprostol before intrauterine device insertion
Abd El-Haseib S. Saad1, Emad El-Din A. Soliman1, Ola M. L. Negm2
1 Department of Obstetrics & Gynecology, Faculty of Medicine, Menoufia University, Menoufia, Egypt 2 Department of Obstetrics & Gynecology, Quesna Central Hospital, Menoufia, Egypt
Date of Submission | 02-Oct-2021 |
Date of Decision | 26-Oct-2021 |
Date of Acceptance | 01-Nov-2021 |
Date of Web Publication | 18-Apr-2022 |
Correspondence Address: Ola M. L. Negm Atef Alsadat, Shibin Elkom Egypt
Source of Support: None, Conflict of Interest: None | Check |
DOI: 10.4103/mmj.mmj_189_21
Objectives To assess the role of vaginal misoprostol before intrauterine device (IUD) insertion. Background Misoprostol is an effective method for the treatment of missed and incomplete abortion, induction of provocative abortion as well as for labor induction and prevention and treatment of postpartum hemorrhage. Moreover, several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women. Patients and methods This is a randomized, clinical trial that included 80 females above the age of 18 years in their fertility period, who want to insert Copper T380 IUD. They were randomly assigned into two equal groups: the first group for vaginal misoprostol and the second group for placebo before IUD insertion. Data were collected and tabulated. Results There was statistically significant difference between the misoprostol group and the placebo group regarding cervical ripening during sound examination and IUD insertion with a P value of 0.000. There was also significant difference in the occurrence of pain with a P value of 0.000 according to visual analog scale. Conclusion Vaginal misoprostol (400 μg) 3 h before IUD insertion in women with past history of cesarean section (no previous vaginal delivery) seems to be associated with higher successful rate of insertion and reduced complications of IUD insertion such as pain and bleeding.
Keywords: cervical ripening, intrauterine device insertion, vaginal misoprostol
How to cite this article: Saad AE, Soliman EE, Negm OM. Role of vaginal misoprostol before intrauterine device insertion. Menoufia Med J 2022;35:240-4 |
Introduction | | |
Intrauterine devices (IUDs) are a good contraceptive method for women as they have a long-acting contraceptive effect compared with other hormonal methods, with an overall unwanted pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years [1].
IUDs are widely used as reversible contraceptives. Copper-bearing IUDs (TCu-380A) are safe, cost-effective on the long term, and equally effective compared with tubal sterilization [2].
The American Congress of Obstetricians and Gynecologists encourages all women to use long-acting reversible contraception [3].
Complications are reported in a considerable proportion of women having an IUD inserted as insertion failures and cervical problems seem to occur more often among women who have never delivered vaginally [4].
Cervical stenosis, immature or small cervix, and significantly anteverted or retroverted position of the uterus have been described as factors associated with difficulty, painful, or even failure to sound the cervical canal [5]. 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 [6].
Misoprostol is an effective method for the treatment of missed and incomplete abortion, induction of provocative abortion as well as for labor induction and prevention and treatment of postpartum hemorrhage [7]. Moreover, several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women [8].
Priming with misoprostol before hysteroscopy and dilatation and curettage and sounding of uterus (in IUD insertion) in premenopausal women resulted in an increased cervical dilatation and a lower rate of cervical laceration [9].
A single dose of 400 μg given vaginally 3 h before the intervention has given the best effectiveness with the least side effects.
Given the benefits of misoprostol before hysteroscopy and sounding of uterus (in IUD insertion), we hypothesized that a cervical ripening agent as misoprostol before IUD insertion reduces failure rates, complications, and pain during insertion [4].
The aim of this study is to assess the role of vaginal misoprostol before IUD insertion.
Patients and methods | | |
This randomized trial was conducted at the Department of Obstetrics and Gynecology at Menoufia University Hospitals and Quesna Central Hospital from the beginning of November 2020 to April 2021 after obtaining their approval. The study protocol was approved by the Medical Ethics Committee of Faculty of Medicine, Menoufia University. It included 80 females above the age of 18 years in the fertility period, who want to insert Copper T380 IUD. All women were informed about the nature of the study and the forms of treatment they would receive, and they signed an informed consent before starting the study. The hospital institutional review board acceptance was obtained before starting the study.
Inclusion criteria were both nulliparous and multiparous women, who delivered by cesarean section (CS) after 4 weeks of delivery or anytime during the menstrual cycle, and those with negative pregnancy test were included in the study.
Exclusion criteria: pregnancy, prostaglandin allergy, copper allergy, PID, unexplained vaginal bleeding, gynecologic malignancy, and before 4 weeks postpartum. The sample size was calculated by assuming that the women submitted to prior use of misoprostol had 44% reduction in moderate to severe pain during IUD insertion compared with the placebo group (RR = 0.56; P < 0.001) [10]; the difference sample size was calculated by Epi info program at power 80% and confidence level 95%. Accordingly, 80 participants will be recruited in the study.
The included women eligible for inclusion criteria were randomly assigned into two equal groups:
Group A (the misoprostol group): insertion was carried out by administering misoprostol according to the following protocol: two tablets of 200 μg misoprostol (total dose of 400 μg misoprostol) taken vaginally (were placed in the posterior fornix, Giza, Egypt) 3 h before IUD insertion (Misotac, 200 μg tablet; Sigma, A.R.E).
Group B (the placebo group): insertion was carried out by placebo (folic acid); placebo was administered according to the following protocol: two tablets of folic acid were placed in the posterior fornix 3 h before insertion (two tablets of folic acid) (folic acid, 500 MCG tablet; Cairo, Egypt, Mepaco, ARE).
Trial is considered successful when successful sounding of the uterus occurred and copper T380 IUD easily inserted after the use of misoprostol.
The included women eligible for inclusion criteria were randomly assigned into two equal groups by means of a computer-generated randomization tables, and their allocations were kept in consecutively numbered, sealed, opaque envelopes till the time of intervention. Each envelope contained one assignment for each participant who will be assigned to either group A or B.
The primary outcomes were effect of misoprostol on cervical ripening and successful IUD insertion. Secondary outcomes were failure of insertion, presence of pain, and bleeding.
Statistical analysis
The recorded data were analyzed using the Statistical Package for the Social Sciences, version 20.0 (SPSS Inc., Chicago, Illinois, USA). Data were expressed as mean and SD. Frequency was expressed in %. χ2 was used to find the association between two or more qualitative variables. Fisher's exact test was used for 2 × 2 tables when the expected cell count of more than 25% of cases was less than 5. Paired sample t test was used when comparing between related samples. P value is considered statistically significant if it is less than or equal to 0.05.
Results | | |
There were no statistically significant differences, as regards the mean age of the study population in both groups, BMI, and the number of previous CS as the P value was 0.725, 0.143, and 0.971, respectively [Table 1]. | Table 1: Comparison between misoprostol and control groups regarding sociodemographic characteristics and past history
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There was statistically significant difference, as regards cervical ripening during sound examination 70 in group A versus 25 in group B with P = 0.000.
IUD insertion in women in group A was more than group B with P = 0.000.
There was statistically significant difference between both groups with regard to the occurrence of pain as P = 0.000 [Table 2]. | Table 2: Comparison between misoprostol and control (placebo) groups regarding the outcome of intrauterine device insertion
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Regarding pain according to the visual analog scale 15 (37.5%) experienced no pain, 13 (32.5%) experienced mild pain 12 (30%) experienced moderate pain in group A in contrast to group B where two (5%) experienced no pain, eight (20%) experienced mild pain, and 30 (75%) experienced moderate pain with a P value of 0.000 [Table 3]. | Table 3: Comparison between misoprostol and control (placebo) groups regarding pain assessment
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Discussion | | |
Our study showed that the use of misoprostol vaginally (400 μg) before IUD insertion increases the success of insertion compared with placebo as we had 28 (70%) women in group A who succeeded to have IUD in place in comparison to 10 (25%) women in group B who had IUD inserted with a P value of less than 0.001, which means that the difference was significant.
This result came in agreement with that of Abdellah et al. [11], who found that vaginal administration of 400 μg misoprostol 3 h before IUD insertion was associated with less difficulty and pain and a higher success rate in women with previous cesarean delivery with no prior vaginal delivery. Also, another study by Bahamondes et al.[12] found that in women with a previous failed IUD insertion, administration of 100 μg misoprostol vaginally 10 and 4 h before reattempting insertion was associated with better results after adjustment for possible confounders.
These results were in agreement with the study done by Black et al. [13], in their clinical trial, where they reported that sublingual administration of 400 μg of misoprostol 1 h before IUD insertion in 47 women with previous CS made insertion significantly easier and reduced the rates of insertion failure.
On the contrary, we disagree with Dijkhuizen et al. [14], who found no significant benefit with regard to insertion failure.
This also disagrees with Lathrop et al. [15], who reported that misoprostol for cervical ripening before IUD insertion does not ease the insertion process nor does it decrease pain, rather it seems to be associated with an increase in reported pain.
Our study showed that using misoprostol before IUD insertion decreases pain during uterine sounding significantly and increased cervical ripening as more patients in group A experienced cervical ripening during sound examination 28 (70%) versus 10 (25%) in group B, P value less than 0.001. Regarding pain and according to visual pain scale 15 (37.5%) experienced no pain, 13 (32.5%) experienced mild pain, 12 (30%) experienced moderate pain in contrast to group B where two (5%) experienced no pain eight (20%) experienced mild pain, and 30 (75%) experienced moderate pain with a P value of less than 0.001.
These results were in agreement with the study by Ward et al.[16] and Scavuzzi et al. [10], who reported that the use of misoprostol at a dose of 400 μg administered vaginally 1 h before IUD insertion increased the ease of insertion and reduced the incidence of pain during the procedure.
Also Scavuzzi et al.[10] reported easier and less painful IUD insertions in nulligravidas administered 400 μg misoprostol vaginally 4 h before the procedure.
These results were in disagreement with the studies by Edelman et al. [17], who published a clinical trial in which 400 μg of misoprostol was used orally 90 min before IUD insertion in 35 women with previous CS and found no significant difference in the pain reported by the women.
We also disagree with Dijkhuizen et al. [14], who performed a randomized controlled placebo trail on a group of nulliparous women, and assessed the difference in dose and time of administration and reported that the use of self-administered misoprostol for cervical ripening before insertion of an IUD does not improve ease of insertion for the provider or decrease reported pain for the patient. Regarding the complications that occurred during IUD insertion, there was statistically significant difference between both groups (regarding bleeding and difficulty of insertion) as we had 15 (37.5%) women, who experienced no bleeding and 25 (62.5%) women, who experienced mild bleeding in group A while two (5%) women experienced no bleeding; 38 (95%) women experienced mild bleeding in group B with P value less than 0.001.
These results were in agreement with the study by Black et al. [13], in their clinical trial, where they reported that sublingual administration of 400 μg of misoprostol 1 h before IUD insertion in 47 women with previous CS made insertion significantly easier and reduced the rates of insertion failure and vaginal bleeding.
But we disagree with Dijkhuizen et al. [14], who reported that the use of self-administered misoprostol for cervical ripening before insertion of an IUD does not improve ease of insertion for the provider or decrease reported pain or bleeding for the patient.
Conclusion | | |
Vaginal misoprostol (400 μg) 3 h before IUD insertion in women with past history of CS (no previous vaginal delivery) seems to be associated with a higher successful rate of insertion and reduced complications of IUD insertion such as pain and bleeding.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]
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