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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 3  |  Issue : 3  |  Page : 661-667

Vaginal or sublingual misoprostol before insertion of an intrauterine device in women who have previously had a cesarean section


Department of Obstetrics and Gynecology, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt

Date of Submission26-Sep-2019
Date of Decision26-Sep-2019
Date of Acceptance17-Nov-2019
Date of Web Publication10-Feb-2020

Correspondence Address:
MD Hanan A.E.M Mohammed
Omar Zaafan St Number 13 flat 602, Nasr City, First District, Cairo, 11765
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/sjamf.sjamf_79_19

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  Abstract 


Background A cesarean section is an operation to deliver a baby. It involves making a cut in the front wall of a woman’s tummy (abdomen) and womb. It makes the procedure of labor easier and safer.
Objective the aim was to investigate whether vaginal or sublingual misoprostol facilitates insertion of an intrauterine device (IUD) in women who have previously had a cesarean section.
Patients and methods This was a randomized clinical study. The study was conducted at Mit Ghammer Maternity Hospital from March 2015 to January 2017. Regarding population of the study, 200 women candidates for TCu-380A IUD insertion were enrolled in the study. Half of them received 400 µg of misoprostol tablets vaginally and the others received sublingually 400 µg of misoprostol tablets.
Results In the present study, 200 women with previous caesarean section and no prior vaginal delivery were included. They were divided into two groups: 100 women received 400 µg of misoprostol vaginally 4 h before IUD insertion, and 100 women received 400 µg of misoprostol sublingually 4 h before IUD insertion. There was no statistically significant difference between both groups regarding age, parity, and number of previous cesarean section deliveries. There was no statistically significant difference between both groups regarding menstrual changes after IUD insertion (first menstruation).
Conclusion Vaginal or sublingual 400 µg of misoprostol administrated 4 h before IUD insertion facilitates IUD insertion and reduces the incidence of pain during the procedure. Vaginal misoprostol is preferred than sublingual route as cervical ripening occurs more likely with vaginal administration.

Keywords: cesarean section, intrauterine device, sublingual misoprostol prior


How to cite this article:
Mohammed NH, Mohammed HA, El-Rahman YM. Vaginal or sublingual misoprostol before insertion of an intrauterine device in women who have previously had a cesarean section. Sci J Al-Azhar Med Fac Girls 2019;3:661-7

How to cite this URL:
Mohammed NH, Mohammed HA, El-Rahman YM. Vaginal or sublingual misoprostol before insertion of an intrauterine device in women who have previously had a cesarean section. Sci J Al-Azhar Med Fac Girls [serial online] 2019 [cited 2020 Feb 29];3:661-7. Available from: http://www.sjamf.eg.net/text.asp?2019/3/3/661/278044




  Introduction Top


A cesarean section is an operation to deliver a baby. It involves making a cut in the front wall of a woman’s tummy (abdomen) and womb. It makes the procedure of labor easier and safer [1].

However, often the cesarean section (CS) makes the cervix stenosed and narrow, so that most of women who have previously had a CS always found it difficult and painful to insert an intrauterine device (IUD) [2].

Misoprostol has been widely used in obstetrics and gynecology. This is a medication that softens the cervix before a variety of processes. It is very effective in reducing abortion-related discomfort, because it makes dilation (opening) of the cervix easier [3].

Several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women [4].

Priming with misoprostol before hysteroscopy and dilatation and curettage in premenopausal women resulted in an increased cervical dilatation and lower rate of cervical laceration because of misoprostol utility for cervical ripening before this procedure [5].

Misoprostol has been assumed to be a safe and useful adjunct both to facilitate the ease of insertion an IUD and to reduce pain experienced by women during this procedure [6].

A study among eight women with an initially failed IUD insertion showed that a second attempt, after pretreatment with misoprostol, was successful in all eight cases [3].


  Aim Top


The aim of this study was to investigate whether vaginal or sublingual misoprostol facilitates the insertion of an IUD in women who have previously had a CS.


  Patients and methods Top


Study design

This was a randomized clinical study. The study was approved by the ethical committe of Al-azhar faculy of medicin for girls.

Setting

The study was conducted at Mit Ghammer Maternity Hospital from March 2015 to January 2017.

Population of the study

Two hundred women candidates for TCu-380A IUD insertion were enrolled in the study. Half of them received 400 µg of misoprostol tablets vaginally, and the other half received sublingually 400 µg of misoprostol tablets.

Inclusion criteria

The following were the inclusion criteria:
  1. Women between 18 and 45 years of age.
  2. Declared their wish for IUCD placement and ability to participate.
  3. No suspension of pregnancy and gave negative result on pregnancy test.
  4. Women with a history of one or more CS deliveries, or women with history of IUD insertion failure or cervical stenosis after CS delivery.


IUD insertion should be done by the same gynecologist.

Exclusion criteria

The following were the exclusion criteria:
  1. Women who had delivered vaginally.
  2. Women with contraindications for misoprostol use (pregnancy and prostaglandin allergy).
  3. Women with contraindications for IUD use (gynecologic malignancy, pelvic inflammatory disease, unexplained vaginal bleeding, and pregnancy).
  4. Nulliparous women.
  5. NSAIDs administration before or after IUD insertion.
  6. Women with previous cervical operations. Participants were allowed to breastfed provided that they would leave an interval of 4 h. between time of administration of misoprostol and breastfeeding.


Methodology

We defined participants as women who never had a vaginal delivery and had undergone CS.

All participants were subjected to the following:

History

Full personal, obstetric, menstrual, and medical history was taken. Data were collected in a special form for each participant.

IUD could be inserted from the third day to the fifth day of the menstrual cycle.

Ultrasound (US) should be done before insertion to detect uterine position (anteverted or retroverted) and any intracavitary pathology (uterine anomaly and fibroid uterus).

Sterile sanitation by a bimanual examination and sounding of the uterus has been used to determine the uterine position and the depth of the uterine cavity and exclude pelvic mass. Then loading of the IUD was done, which was inserted gently inside the uterus through the cervical canal. Examination was done by US to ensure the position of IUD after application.

Participants were randomly allocated to either the vaginal group or sublingual group.
  1. Group 1 received two tablets of misoprostol deep in vagina near to cervix 4 h before loop application.
  2. Group 2 received two tablets of misoprostol sublingual within 4 h before application.


In case of failure of IUD insertion, a second trial of IUD application was done during the next menstruation.

Study outcome measures

The primary outcome measure of this study was the proportion of failed IUD insertions defined as an unsuccessful insertion, regardless of the reason (e.g. immediate expulsion or impossibility to sound the uterus or any resistance were recorded or stenosed os).

Secondary outcome measures were vasovagal-like reactions (dizziness, nausea, and vomiting), syncope, partial or total expulsion, heavy bleeding, uterine or cervical perforation, and pain during insertion, as estimated by the inserter ([Table 1]).
Table 1 The numeric rating scale is an 11-point scale for patient self-reporting of pain

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Both the participant and the clinician filled out the scale immediately after the insertion procedure.

All participants were seen for a routine check-up 6 weeks after IUCD insertion. During this visit, vaginal examination and/or vaginal US were performed.

IUCD expulsions and infections were recorded.

The collected data were organized, tabulated, and analyzed using appropriate statistical tests.

Statistical analysis of the data

Data were fed to the computer and analyzed using IBM SPSS software package version 20.0, (IBM Corp., Armonk, New York, USA). The P value is defined as the probability, under the null hypothesis H, of obtaining a result equal to or more extreme than what was actually observed. Depending on how it is looked at, the ‘more extreme than what was actually observed.’ The smaller the P value, the larger the significance. If P value is less than 0.05, the result will be significant. If P value is more than 0.05, the result will be nonsignificant.


  Results Top


[Table 2] shows both groups were comparable regarding age, parity, number of CS, and duration of last CS in months.
Table 2 Demographic data of both groups

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[Table 3] shows no significant difference in the position of the uterus between both groups (P=1.0).
Table 3 The position of the uterus detected by vaginal examination of both groups

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[Table 4] shows no statistically significant difference between both groups regarding the success rate from first and second attempts (which was during next cycle) and also the causes of failure.
Table 4 The success rate of intrauterine device insertion from first or second attempt in both groups

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[Table 5] shows the comparison between both groups according to the complication of insertion.
Table 5 The complications of insertion in both groups

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[Table 6] shows there is a highly statistically significant increase in pain during IUD applications in group II than group I (P=0.001).
Table 6 Visual analog scale in both groups

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[Table 7] shows there was no significant difference in postinsertion US follow-up, infection, or changes in postinsertion menstruation between the two groups.
Table 7 Follow-up 6 weeks after intrauterine device insertion in both groups

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  Discussion Top


In women with previous cesarean section and no prior vaginal delivery, health care personnel may be reluctant to insert an IUD, as this procedure is perceived as risky, with potential complications including failure of insertion, pain during insertion, and perforation [4].

In the present study, 200 randomized patients were trialed from April 2015 to January 2017, evaluating the effect of misoprostol before IUD insertion exploring whether IUD insertion in such patients could be facilitated, with a view to increase the acceptability and use of this highly effective and reliable method of contraception among women and health care providers.

Prostaglandin Ei analog (misoprostol) use has been described in a series of articles. This is a synthetic prostaglandin, which is marketed as an antiulcer agent under the trade name Cytotec [7]. Misoprostol tablet, which can be crushed and placed on the cervix, has been shown in many studies to be quite effective in inducing cervical ripening and labor [8].

In the present study, 200 women with previous caesarean section and no prior vaginal delivery were included. They were divided into two groups: one hundred women received 400 µg of misoprostol vaginally 4 h before IUD insertion and 100 women received 400 µg of misoprostol sublingually 4 h before IUD insertion. There was no statistically significant difference between both groups regarding age, parity, and number of previous CS deliveries.

The present study found that there was no statistically significant difference in the position of the uterus (AW and RW) between both groups and these results were in agreement with the study done by van Valkenhoef et al. [9].

In the present study, the use of misoprostol at a dose of 400 µg vaginally or sublingual before IUD insertion was found to be associated with successful insertion on the first attempt in 94% in vaginally administrated group and 97% in sublingual group; these results were not statistically significant (P=0.498).

These results were in agreement with the study done by Black et al. [10] 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, Haddad et al. [11] 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.

In the present study, failure of IUD insertion was detected in 6% of vaginally administrated group; half of them only were succeeded in the second attempt (during next menstruation). The main cause of failure of IUD insertion was owing to stenosed os in 3.3% of failed cases and 6.7% owing to inaccessible cervix.

However, in the sublingual administrated group, there was 3% IUD insertion failure rate, and only a third of them succeeded in the second attempt (during next menstruation). A third of them were due to stenosed os and the other were owing to inaccessible cervix.

Vaginal misoprostol is associated with slower absorption, lower peak plasma levels, and slower clearance and greater effect on the cervix and uterus [12]. In contrast to the sublingual route, the plasma concentration increases gradually after vaginal administration, reaching its maximum level after 70–80 min before slowly declining with detectable drug levels still present after 6 h [13].

Both vaginal and sublingual misoprostol are effective in cervical ripening before IUD insertion, but it appears from shorter introduction interval in vaginal and higher acceptability that vaginal route is a better choice.

Regarding the complications that occurred during IUD insertion, there is no statistically significant difference between both groups (regarding perforation, heavy bleeding, difficulty of insertion, and vasovagal-like reaction); these results were in agreement with the study done by Li et al. [14], Ward et al. [15] and Scavuzzi et al. [16], 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 complications that occurred during IUD insertion.

These results were in disagreement with the studies done by Dijkhuizen et al. [3] and Guttmacher Institute [17] who performed a randomized controlled placebo trail on a group of nulliparous women, and assessed the difference in dose and time of administration. Dijkhuizen et al. [3] 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.

There is a statistically significant difference between both groups regarding pain during IUD insertion, with P value of 0.004. Administration of misoprostol before IUD insertion was significantly associated with almost threefold reduced pain during insertion in vaginal group (0.18%) than sublingual group (0.38%).

These results were in agreement with the study done by Scavuzzi et al. [16]. Scavuzzi et al. [16] 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 [16].

These results were in disagreement with the study done by Dijkhuizen et al. [3] where they gave oral analgesics and antispasmodic in addition to misoprostol to overcome the adverse effects of misoprostol.

Dijkhuizen et al. [3] 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.

Edelman et al. [2] 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.

Pain caused by vaginal administration of misoprostol was found to be mild with 18% of cases belonging to this group experiencing no pain, whereas in the sublingual route, pain would range from moderate to severe [18].The present study showed a statistically significant difference between both groups regarding visual analog scale, with P value of 0.001.

These results were in agreement with the study done by Ward et al. [15] and Scavuzzi et al. [16].

These results were in disagreement with the study done by Dijkhuizen et al. [3] and Guttmacher Institute [17].

Follow-up of both groups after 6 weeks revealed that there is no statistically significant difference between both groups regarding US examination or occurrence of infection.

These results were in agreement with the study done by Scavuzzi et al. [16] and Saav et al. [18].

Saav et al. [18] reported that there is no relation between route of misoprostol administration before IUD insertion and occurrence of infection.

These results were in disagreement with the study done by Scavuzzi et al. [19] and Dijkhuizen et al. [3] who reported that IUD insertion increases the rate of vaginal infection and even pelvic inflammatory diseases (PID).

Bahamondes et al. [1] reported the association between IUD use and vaginal infection may be mediated by irregular vaginal bleeding. Intermediate flora is associated with an increased incidence of vaginal infections.

There was no statistically significant difference between both groups regarding menstrual changes after IUD insertion (first menstruation).


  Conclusion Top


For IUD insertion in women who delivered only by CS, we concluded the following:
  1. Vaginal or sublingual 400 µg of misoprostol administered 4 h before IUD insertion facilitates IUD insertion and reduces the incidence of pain during the procedure.
  2. Vaginal misoprostol is preferred than sublingual route as cervical ripening occurs more likely with vaginal administration.
  3. Repeated attempts of misoprostol in the next cycle may be beneficial when a previous insertion attempt has failed.


Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]



 

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