Archives of International Surgery

ORIGINAL ARTICLE
Year
: 2018  |  Volume : 8  |  Issue : 2  |  Page : 63--68

A randomized comparison of patient satisfaction with oral and vaginal misoprostol for induction of labor at term


Umar S Hauwa1, Oladapo S Shittu1, Bala M Audu2, Hajaratu–Sulayman Umar1,  
1 Department of Obstetrics and Gynaecology, Ahmadu Bello University Teaching Hospital Zaria, Kaduna State, Nigeria
2 Department of Obstetrics and Gynaecology, Abubakar Tafawa Balewa University Teaching Hospital, Bauchi State, Nigeria

Correspondence Address:
Dr. Umar S Hauwa
Department of Obstetrics and Gynaecology, Ahmadu Bello University Teaching Hospital Zaria, Kaduna State
Nigeria

Abstract

Background: Induction of labor has the potentials for preventing maternal complications and improving pregnancy outcome especially in low-resource settings like Nigeria. The various routes of administration of misoprostol have been proven to affect the safety and efficacy of the drug. However, there is paucity of studies that compared the satisfaction of women regarding the oral and vaginal routes. The aim of this study is to compare patient satisfaction with administration of oral and vaginal misoprostol for induction of labor at term. Patients and Methods: A randomized comparative study, where 169 women admitted for induction of labor at the delivery suite of Ahmadu Bello University Teaching Hospital were assessed for their satisfaction with regard to the oral and vaginal routes of misoprostol administration using the 5-point Likert scale. Data were analyzed using SPSS version 20. Results: The request for analgesia was similar in both groups [17.9% vs 17.9%, relative risk (RR); 1.00 95% confidence interval (CI) 0.5–1.9]. However, more women in the oral group were very satisfied compared with the vaginal group (57.6% vs 33.3%), and a significant proportion of women in the oral group expressed their willingness to use the same route of labor induction in subsequent pregnancies (RR 1.1, 95% CI 1.0–1.3, P = 0.04). There was no difference in terms of maternal and neonatal outcomes for both routes. Conclusion: Women had higher satisfaction with oral misoprostol and preferred the oral route compared with the vaginal route.



How to cite this article:
Hauwa US, Shittu OS, Audu BM, Umar H. A randomized comparison of patient satisfaction with oral and vaginal misoprostol for induction of labor at term.Arch Int Surg 2018;8:63-68


How to cite this URL:
Hauwa US, Shittu OS, Audu BM, Umar H. A randomized comparison of patient satisfaction with oral and vaginal misoprostol for induction of labor at term. Arch Int Surg [serial online] 2018 [cited 2019 Sep 20 ];8:63-68
Available from: http://www.archintsurg.org/text.asp?2018/8/2/63/259463


Full Text



 Introduction



Induction of labor has the potentials for preventing maternal complications and improving pregnancy outcome especially in low-resource settings like Nigeria.[1],[2] The rate of induction of labor is lower in African countries and differs from one institution to another in Nigeria.[3],[4],[5] The success of induction of labor depends on proper patient selection, with consideration of factors such as parity, gestational age, estimated fetal weight, prior uterine surgery, and cervical status.[6] The wishes and preferences of each woman should also be considered.[2]

Misoprostol can be administered through several routes: vaginal, rectal, buccal, oral, or sublingual. The different routes of misoprostol administration have strong impact on the pharmacokinetic profile which results in different clinical efficacy.[7] Peak plasma concentration of misoprostol active metabolite is reached 30 min after oral administration and declines rapidly after 120 min with low levels remaining thereafter, whereas peak plasma concentration of misoprostol is reached 70–80 min after vaginal administration of misoprostol, with detectable drug levels after 6 h.[7] Hence, the oral route requires more frequent dosing every 2 h, whereas the vaginal route requires dosing every 6 h.

More adverse effects have been reported in the vaginal route irrespective of the dose used, whereas the oral route revealed more safety in terms of reduced risk of caesarean births, hyperstimulation with fetal heart rate changes, and decreased risks of adverse maternal or perinatal outcome.[2],[8],[9],[10] Other reported side effects such as nausea, vomiting, diarrhea, and abdominal cramps were more common after oral or sublingual administration.[2],[11],[12],[13] The oral and sublingual routes have additional advantages of ease of administration, greater freedom of position after insertion, and decreased pelvic examinations.[14],[15] However, only a few studies compared patient satisfaction and preference of oral versus vaginal misoprostol for induction of labor at term.[14],[16] Previous studies also used high dose (50 μg) of misoprostol with wider interval of administration (4–6 hourly). Hence, this study aims to compare patient satisfaction with equal low-dose (25 μg) misoprostol administered 2 and 6 hourly through the oral and vaginal routes, respectively.

 Patients and Methods



This randomized study was conducted on 169 women admitted into the delivery suite of the Department of Obstetrics and Gynaecology, Ahmadu Bello University Teaching Hospital Zaria from May 2014 to June 2015 after obtaining ethical approval from the institution's ethical clearance committee. Eligible participants were pregnant women with a specific indication for induction of labor, parity of 0–4, gestational age of 38–42 weeks, singleton fetus, vertex presentation, cardiotocographic evidence of a reactive fetal cardiac activity, and Bishop score ≤5. The following category of patients were excluded from the study: those with multiple gestation, malpresentation, nonreactive fetal cardiac activity, previous uterine surgeries, those already in labor (having at least one painful uterine contractions in 10 min), and women with medical conditions such as sickle cell anemia, mitral valve stenosis, glaucoma, and known hypersensitivity to prostaglandins.

Sample size calculation and randomization of patients

The minimum sample size was determined using the proportion outcome formula for a two-sided test of 5%: m = c × π1(1 − π1) + π2(1 − π2)/(π1− π2)2. Where m is the size per group, c is given as 7.9 for 80% power, while the proportion estimates π1 and π2 were calculated as 0.82 and 0.62, respectively.[17] A sample size of 169 was used after correction for attrition rate of 10%. The women were categorized into two groups by computer randomization: 85 women in vaginal misoprostol group and 84 women in oral misoprostol group. The conditions of the study were completely explained to the women, and written informed consent was obtained before commencement of the study. The allocation was done by opening sequentially numbered folded forms with already stamped routes of administration.

Procedure and management

Routine clinical evaluation and laboratory investigations were done including urinalysis, hematocrit, grouping and cross matching at least a unit of compatible blood, and preliminary cardiotocogram (CTG). A repeat CTG was done whenever abnormality in the fetal heart rate was detected and more frequently in high-risk patients. A written consent was obtained from every participant. Demographic data of the patients including age, parity, reason for induction, gestational age, and admitting Bishop scores were recorded. The oral misoprostol group each received 25 μg of misoprostol every 2 h with 20 mL of water, whereas the vaginal group received the same 25 μg every 6 h until adequate uterine contractions of 3 in 10 min were achieved or for maximum of 24 h duration. A partograph was completed for each patient and labor monitored according to standard labor ward and national protocols. Each patient was monitored for complications and side effects of the drug such as uterine hyperstimulation (a contraction lasting at least 2–3 min or more than five contractions per 10 min lasting greater than 45 s), vaginal bleeding, nausea, vomiting, diarrhea, fever, need for analgesia, genital tract lacerations, primary postpartum haemorrhages, need for intensive care admission, and fetal complications such as cardiotocographic changes, meconium-stained liquor, fetal distress, fetal demise, still birth, birth asphxia, and need for special care baby unit. Whenever an untoward observation was made requiring intervention such as fetal distress or uterine hyperstimulation, the next dose of misoprostol was withheld, the patient and/or baby was resuscitated, and an alternative mode of delivery was then considered based on the prevailing obstetric and clinical conditions. Induction of labor was declared unsuccessful or failed when active labor was not established within 24 h or the process had to be abandoned for some exigency. Augmentation of labor with oxytocin was used when considered necessary, 6 h after the last dose of misoprostol for both routes. The satisfaction of each patient was assessed using the 5-point Likert-type scale ranging from “very satisfied” to “very dissatisfied” before discharge. The responses of the patients were entered into a structured pretested questionnaire.

Outcome measures

The main outcome was the proportion of patients satisfied with each route of administration of misoprostol. Patient satisfaction was defined as the overall expression of satisfaction with the whole process of induction through each route and willingness to use the route of administration again in subsequent pregnancy. The 5-point scale was listed from 1 to 5 descriptors, which were read out to the patient by the discharging doctor as one “very satisfied,” two “moderately satisfied,” three “neither satisfied nor dissatisfied,” four “dissatisfied,” and five “very dissatisfied.”[18] Other outcome measures include induction–delivery interval, need for analgesia, number of failed induction of labor, maternal and fetal adverse effects such as nausea, vomiting, diarrhea, fetal distress, apgar score <7 at 5 min, and neonatal intensive unit admission (NICU).

Data analysis

Data were analyzed using Statistical Packages for Social Science (SPSS) version 20 software. The qualitative variables such as patients' level of satisfaction, adverse effects of misoprostol due to different routes of administration, and maternal and fetal outcomes were analyzed by their percentages and compared using Chi-square test of proportions. P value of < 0.05 was considered statistically significant.

Ethical consideration

Approval for this study was obtained from the Ethical Committee of Ahmadu Bello University Teaching Hospital Shika-Zaria and the study site. Also, the study protocol was explained to all participants and a written informed consent was obtained before recruitment into the study.

Funding

All the expenses incurred in carrying out this study were borne by the researcher.

 Results



The mean gestational age (39.19 ± 7.44 vs 38.7 ± 10.06), Bishop score (2.93 ± 0.87 vs 2.90 ± 0.97), and parity (2.19 ± 1.24 vs 1.86 ± 1.31) of the pregnant women were within the same mean and standard error of the mean for both the oral and vaginal routes. The most common indication for induction of labor from the study was prolonged pregnancy, while pregnancy-induced hypertension was the second common indication [Table 1]. The need for analgesia (17.6% vs 17.9%) was comparable in both groups. Induction to delivery interval (hours) was significantly faster with the oral route (18.48 ± 8.17) compared with the vaginal (22.82 ± 6.80). Failed induction of labor was not statistically significant and was 10.6% in the oral group and 11.9% in the vaginal group. The maternal adverse effects of the drug such as nausea, vomiting, and diarrhea were comparable with both routes and not statistically significant. Neonatal outcomes such as Apgar score < 7 at 5 min [relative risk (RR) =0.6; 95% confidence interval (CI): 0.1–6.7] and NICU admission (RR = 1.8; 95% CI: 0.3–10.5) were comparable in both groups.{Table 1}

The proportion of women who were “very satisfied” with the oral route 49 (57.6%) was higher than the proportion from the vaginal route 28 (33.3%). None of the respondents was “very dissatisfied” with either the oral or the vaginal route [Table 2], [Figure 1]. Most of the women believed that the oral route was more convenient and gave them freedom to take the drug themselves under observation, unlike the vaginal route that required a pelvic examination.{Table 2}{Figure 1}

The willingness of the women to use the oral route in subsequent pregnancy was higher and statistically significant in the oral group compared with the vaginal group (90.6% vs 80.6%, RR 1.1, 95% CI 1.0–1.3, P = 0.04). The proportion of women not willing to use the vaginal route in future induction doubled those in the oral group (19.1% vs 9.4%, RR 0.4, 95% CI 0.2–1.0) and was statistically significant. The overall experience with induction of labor in the oral group was more favorable to women and was most preferred as a route of induction of labor in future pregnancies [Table 3], [Figure 2].{Table 3}{Figure 2}

 Discussion



This study compared equal and low-dose misoprostol (25 μg) through the oral and vaginal routes for labor induction at term adding to the few existing studies like that of Kundodyiwa et al. who compared equal and low-dose (20 μg) misoprostol through the oral and vaginal routes in a systematic review of two studies.[19] The mean gestational age, Bishop score, and parity for both routes were comparable to that reported by Khadija et al. with no statistical difference.[20] The success of induction of labor was reported to be affected by gestational age, Bishop score, and parity.[6] However in this study, these parameters were restricted by the study design (gestational age: 38–42 weeks, Bishop score: 0–5, and parity: 0–4). Prolonged pregnancy was similarly reported to be the most common indication for the induction of labor by Bako et al. in Maiduguri and Ekele et al. in Sokoto.[4],[5] However, an earlier Zaria study, by Abdul et al., reported hypertension in pregnancy as the most common indication for induction of labor.[17] However, the reason for such disparity could be explained by the fact that only term pregnancies (38–42) were used in this study, while the modal gestational age of the women with pregnancy-induced hypertension in the preceding Zaria study was 36 weeks. The induction delivery interval (I-D) was significantly shorter with the oral route compared with the vaginal. Similar studies by Kombhampti et al. reported shorter I-D for the oral route.[21] However, other studies by Rasheed et al. and Shetty et al. reported shorter I-D for the vaginal route against the oral route.[22],[23] Variation in the I-D can be explained by the lack of homogenicity in the dosing frequency for the oral route. For example, the same doses of 50 μg were used for both the oral and the vaginal routes by Rasheed et al., but the dosing frequency was every 4–6 h, which was too long for the bioavailability of the oral drug of just 2 h.[7] Other parameters such as Bishop scores, gestational ages, and parity can affect the I-D if not carefully selected.[6]

Similar to Shetty et al.'s report, the need for analgesia was nearly the same for both the routes and not statistically significant.[14] The adverse effects of the drug such as nausea, vomiting, diarrhea, and neonatal outcomes were comparable to the findings of Kundodyiwa et al. who also used equal and low-dose misoprostol.[19]

Vaginal route of administration of misoprostol is the most common route of administration, but studies have demonstrated its nonacceptance due to social reasons.[24] Medical staff responsible for administering misoprostol were reported to have preference of the oral or sublingual routes compared with the vaginal.

From our knowledge, this study is the first to compare patient satisfaction with the oral and vaginal routes using equal and low-dose misoprostol: 25 μg, 2 hourly in the oral group versus 25 μg 6 hourly in the vaginal group. However, previous studies by Shetty et al. and Ezechukwu et al. used a higher dose of misoprostol 50 μg every 4 h for both the routes.[14],[16] Contrary to our study, Shetty et al. reported higher satisfaction rate in the vaginal group (89.1% vs 74.5%, RR 1.2, 95% CI 1.04–1.4) that was attributed to fast induction in the vaginal group and slow induction in the oral group. However, the highest level of satisfaction in this study was with the oral route (57.6% vs 33.3%), which can be explained by faster induction in the oral group compared with the vaginal. Similarly, Shetty et al. reported a higher preference to use the oral route (49% vs 15.8%) compared with the vaginal route in subsequent induction due to ease of administration, less invasiveness, and no restriction to movement. Majority of the women in this study expressed their opinion regarding the oral route as more convenient and gave them freedom to take the drug themselves, unlike the vaginal route that required a pelvic examination by a medical staff. Shetty et al. reported higher number of women who were unsure of which method they will prefer in next induction (41.8% from oral group vs 35.3% from vaginal group), while this study reported fewer number of women in the oral group compared with the vaginal group (9.4% vs 19.1%) who clearly stated that they will not use the routes again. This finding did not temper with their previous high preference of use in future induction. However, Ezechukwu et al. reported comparable satisfaction between the two routes. The need for analgesia due to pain was comparable to both the routes similar to that reported by Shetty et al. However, the single analgesic use in this study was pentazocine, while Shetty et al. compared several analgesics like entonox, morphine, and epidural. One limitation of this study was that the pain scoring scale was not used. However, Shetty et al. and Nasser et al. have previously reported no statistical significant difference in pain scores assessed by Visual Analog Scale for both the routes.[14],[15]

The peculiarity of this study is the use of the equal doses and frequency of dosing to be compatible with the bioavailability of each route.[7] The oral route dosing was every 2 h, whereas the vaginal route dosing was every 6 h according to World Health Organization's recommendation.[25] This minimized the repeated vaginal examination that was discomforting to most parturients and yielded effective result with the oral route and improved the safety of the vaginal route. More large-scale studies with similar dosing regimen need to be conducted.

 Conclusion



Women were very satisfied and preferred the oral route of administering misoprostol compared with the vaginal route for labor induction at term. However, large powered studies using the same dosing regimen and routes need to be conducted to ascertain the efficacy and safety of the oral route compared with the vaginal.

Recommendations

The 25-μg misoprostol should be added to the essential drug list in our local settings, to discourage the breaking of 200 μg misoprostol, or dissolving it in water before use.The administration of the 25-μg oral dose of misoprostol for induction of labor can be a better choice in local settings where continuous fetal monitoring cannot be ensured.The dosing regimen (25 μg every 2 h) for the oral route should be adhered to, rather than a higher oral dose with a longer dosing interval, for example, 50 μg every 4 h.Women, for induction of labor with misoprostol, should be allowed to choose the route of their preferences after adequate counseling.Larger and adequately powered studies are needed from various institutions and countries to ascertain the efficacy and safety of the same dose and dosing frequency.Studies on induction of labor should always assess patients' satisfaction and preference for each route of administration.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

References

1Fawole B, Wafiou I, Machoki M, Wolomby M, Jean J, Mugerwa K. Unmet need forinduction of labor in Africa: Secondary analysis from the 2004-2005 WHO global maternal and perinatal health survey. BMC Public Health 2012:12;722.
2Recommendations for Induction of Labor WHO. Geneva: World Health Organization; 2011.
3ObunaJA, Umeora OUJ, Ejikeme BN, Agwu UM. Pre-induction and intrapartum correlates of successful induction of laborusing oxytocin and misoprostolin Abakaliki, Nigeria. Ebonyi Med J2010;9:2.
4Ekele BA, Nnadi DC, Gana MA, Shehu CE, Ahmed Y, Nwobodo EI. Misoprostol use forcervical ripening and induction of labor in a Nigerian teaching Hospital. Nijer J Clin Pract 2007;10:234-7.
5Bako BG, Obed JY, Sanusi I. Methods of induction of labor at the university of Maiduguri teaching hospital, Maiduguri: A 4- year review. Niger J Med 2008;17:139-42.
6Frank W, Lawrence D. Update on Successful Induction of Labor. Adv Stud J Med 2005;5:5888-98.
7Zieman M, Fong SK, Benowitz NL, Banskter D, Darney PD. Absorption kinetics of misoprostol with oral or vaginal administration. Obstet Gynecol 1997;90:88-92.
8Abdel-Aleem H. Misoprostol for cervical ripening and induction of labor: RHL commentary. The WHO Reproductive Health Library. Geneva: World Health Organization; 2011.
9Hofmeyr GJ, Gülmezoglu AM, Alfirevic Z. Misoprostol for induction: Asystematic review. Br J Obstet Gynaecol 1999;106:798-803.
10Sultana N, Rauf S, Rashid M. Oral vsvaginal misoprostol for induction of labor. J Bangladesh Coll Phys Surg 2006;24:44-9.
11John C, Line L, Gregory JR. SOGC clinical practice guideline. J Obstet Gynaecol Can 2001;27:717-28.
12Abdul MA, Shittu SO, Ameh N, Khan T. Effectiveness of misoprostol in the management of intrauterine foetal death. Ann Afr Med 2006;5:174-7.
13Tang OS, Gemzell-Danielsson K, Ho PC. Misoprostol: Pharmacokinetic profiles, effects on the uterus and side-effects. Int J Gynaecol Obstet 2007;99:S160-7.
14Shetty A, Danielian P, Templeton A. A comparison of oral and vaginal misoprostol tablets in induction of labor at term. BJOG 2001;108:238-43.
15Nassar A, Awwad J, Khalil A, Abu-Musa A, Mehio G, Usta I. A randomized comparison of patient satisfaction with vaginal and sublingual misoprostol for induction of labor at term. BJOG 2007;114:1215-21.
16Ezechukwu PC, Ugwu EO, Obi SN, Chigbu CO. Oral misoprostol for induction of labour in Enugu, Nigeria: A randomized controlled trial. Arch Gynecol Obstet 2015;291:537-44.
17Abdul MA, Ibrahim UN, Yusuf MD, Musa H. Efficacy and safety of misoprostol ininduction of labor in a Nigerian tertiary hospital. West Afr J Med 2007;26:213-6.
18Dawes J. Do data characteristics change according to the number of scale used? An experiment using 5-point, 7-point and 10-point scales International journal of market research 2008;50:61-77.
19Kundodyiwa TW, Alfirevic Z, Weeks AD. Low-dose Oral Misoprostol For Induction Of Labour: Asystematic review. Obstet Gynecol 2009;113:374-83.
20Bano K, Mahjabeen Bhutta SZ. Oral versus vaginal misoprostol for induction of labour at term. J Surg Pak Int 2009;14:33-7.8.
21Kombhampati K, Meherlatha R, Iqbal JQ, Suneetha B, Ramya V. Comparative study of oral and vaginal misoprostol for induction of labour: Materal and foetal outcome. J Clin Diagn Res 2013;7:2866-9.
22Rasheed R, Alam AA, Younus S, Raza F. Oral versus vaginal misoprostol for labourinduction. J Pak Med Assoc 2007;57:404-7.
23Shetty A, Livingstone I, Acharya S, Danielian P, Templeton A. Oral misoprostol versus vaginal misoprostol in term labourinduction. A randomized comparison. Acta Obstet Gynecol Scand 2003;82:1103-6.
24Aronsson A, Bygdeman M, Gemzell-Danielsson K. Effects of misoprostol on uterine contractility following different routes of administration. Hum Reprod 2004;19:81-4.
25Global Survey on Maternal and Perinatal Health: Induction of Labour Data. Geneva: World Health Organization. WHO 2010. Available from: http://www.who.int/reproductivehealth/topics/best_practices/global_survey. [Last accessed on 2013 Mar 25].