4 Metodología
4.3 El seguro social campesino
This study was a randomized control trial of pregnant women of various socio-economic background and ethnicity who had emergency caesarean section at university of Abuja teaching hospital, Gwagwalada, Nigeria. These women were recruited at the time they were notified of the indication for the emergency caesarean section and were randomly assigned
35
to any of the two groups, control versus intervention group (povidone iodine group) as was done elsewhere 8,27,28 . Those in the povidone iodine group had their vagina cleansed with 10% povidone iodine while those in the control group had no such procedure as was done in similar studies 8,27,28. Routine prophylactic antibiotics as prescribed by CDC (iv. ceftriaxzone 1000mg and iv metronidazole 500mg),41 routine cleaning and draping as well as post-operative antibiotics were giving as was done by Memon SL etal in Hyderbad, Pakistan studies28.
At booking, out of the 260 women recruited 131(50.4%) were in the control group while 129(49.6%) were in the povidone iodine group which showed approximately equal representation for each group as was seeing in other studies 8,27,28. The mean age of the participants analysed using t –test in the control group was 28.5±4.8 years and in the povidone iodine group was 29.1±4.7 years; this was similar to the mean age of 27.1±4.6 in the control group and 27.2 ±5.0 in the treatment group of similar studies done in Pakistan.28 Women at the age range of 24-29 years and 30-35years were significantly high ( 95% CI=5.9;
p=0.015) vs ( 95% CI=6.2; p=0.012) respectively. This was similar to demographic features on women who had caesarean section in kanoby Jido TA et al which showed higher rate of 17%
of pregnant women within the age range of 25-29 years, followed by 7% in those of 30-35years range.38 This is probably because Abuja is an urban environment with people of civil service oriented jobs whose earlier pursuance of education tends to delay their reproductive carrier (marriage and pregnancy).
Educational level of the women did not show any statistical significance association between the control or povidone group. However, those with tertiary level of education were more with 78(59.5%) participants in the control group and 77(59.7%) participants in the povidone iodine group. The number of participants decreases with decrease ineducational level and illiteracy was lowest 4(3.1%) for each of the two groups. This may be due to the fact that, Abuja city, being the federal capital of Nigeria is mostly populated by civil servants and educated people who are looking for greener pastures. The lower value of illiterates and higher value of literates in urban regions was similar to report from an unrelated study done in Ghana.
36
Nigeria is a multi-ethnicity region and none of the tribes was significantly higher than the other between the control or povidone iodine groups. However, other (mixed minority) tribes were more 59(45.0%) in control group and 59(45.7%) in the povidone iodine group. This may be because of the federal character nature of the federal government in terms of employment.77 This study did not show any statistical significance relating to women’s job.
However, majority were professionals 47(35.9%) in the control group and 44(34.1%) in the povidone iodine group. The least were skilled agricultural, forestry and fishery workers 2(1.2%) vs 1(0.8%). This might be due to the civil service nature of most jobs in Abuja.
The booking status did not show any statistical difference between the control and povidone iodine groups (p=0.700). This was similar to report by Jidoet al.38 But we have more booked women. This was probably because most women were literate and therefore, more informed. For parity, the para 0 women were more in the control group 40(30.5%) while para 1 were more in the povidone iodine group 31(24.0%) but none was significantly higher (p=0.186) vs (p=0.945). This is slightly lower than report by Memon et al where by the mean parity of participants in a similar studies were 2.51±2.27 in the control group and 2.40±2.25 in the povidone iodine group.28 The higher number of low parity might be because most women in the urban area like Abuja, start their reproductive carrier late due to pursuance of education up to tertiary level (which was recorded to be highest in this study) and also due to increased awareness of contraception and family planning among the educated individuals.
The gestational age did not show any statistical significant (p=0.371), however, those at 28 to
< 37weeks gestational age were more, 63(48.1%) in the control group and 65(50.4%) in the povidone iodine group. This was similar to studies by Memon et al where by the mean geatational age was 36.86±2.46 in the control group and 36.65±2.05 in the treatment group.28 The post-term participants at recruitments were very few with 12 (9.2%) in the control group and 8 (6.2%) in the povidone iodine group (p=0.371). This was similar to most studies, due to probably routine elective induction of labour to prevent post-term pregnancy and its complications.8,26,27,28 Other obstetrics and surgical factors such as number of vaginal examinations (p=0.051), duration of labour prior to caesarean section (p=0.144), membrane integrity (p=0.478) and duration of caesarean section (p=0.122) did not show any significant association at recruitment.8,26,27,28
37
Endometritis was the primary outcome in this study. Out of 131 participants in the control group, 18 (13.7%) had endometritiswhile out of 129 in the povidone iodine group, 4(3.1%) developed endometritis. The rate of post-caesarean section endometritis in the control group (13.7%) was similar to the rate of puerperal sepsis recorded in a recent nationwide study on maternal deaths and near-misses in Nigeria (14.2%).20 It is also within the range of post-operative wound infections following caesarean section ( 0 to 20.5%) reported in a hospital survey conducted by Moir-Bussy and colleagues.37 However, the 3.1% rate of endometritis in the povidone iodine group showed significant advantage over the 13.7% rate in the control group. Similar beneficial outcome (7.2% vs 3.6%) was recorded in the analysis of five randomized control trials by Haas DM et al and (7% vs 1%) by Memon et al as well as other studies. 8,26,27,28,29
The analysis of demographic factors did not show any significant difference in developing endometritis between the control and povidone iodine groups. These were maternal age (p=0.210), educational level (p=0.746), ethnicity (p=0.135) and occupation (p= 0.470) of the participants (lowest p values). The result was similar to the outcome of studies by Reid et al which showed no difference in developing endometritis between groups in maternal age, parity, race, education, prior caesarean section, type of anesthesia, labour before current caesarean section, number of vaginal examinations during labour, internal monitoring, prophylactic antibiotic use, gestational age at delivery, or payment status.29 Other studies showed similar results. 8,26,27,28
Obstetric factors like ruptured membranes prior to caesarean section with no treatment 14(77.8%); 0.1(0.01-1.2), p=0.040 appears to cause significant endometritis than those in the povidone iodine group. This is similar to report by Haas DM et al where by women with ruptured membranes prior to caesarean section had significant decrease in endometritisfrom 15.4% in the control group to 1.4% in the treatment group.8 This may be due to inhibition of growth and ascent of bacteria from the vagina in to the endometrial cavity by the effect of povidone iodine. Duration of labour of ≥24hrs in the control group was significantly high in causing endometritis 10(55.6), 1.3(0.1-10.9); p=0.040. Similar result was reported by Memon SL et al.28 However, this variable was not mentioned in most studies probably because similar studies were done in more developed countries where most labours and deliveries are supervised and not allowed to prolong.8
38
Women who present with prolonged labour are usually associated with other compounding factors such as unbooking status, low socio-economic status, malnutrition, anaemia, prolonged rupture of membranes and dehydration. These factors might have independently increased the risk of endometritis among them. Other obstetrics and surgical factors in this study such as booking status (p=0.269), parity (p=0.696), gestational age (p=0.601), number of vaginal examinations (p=0.386) and duration of caesarean section (p=0.380) didnot show any significant difference in developing endometritis as was reported by Haas DM et al in 5 randomized control trials and other studies. 8,26,27,28,29 Adverse reaction to povidone iodine was not recorded as was shown in other studies. 8,26,27,28,29,70 This study reaffirms its safety.
Wound infection was the secondary outcome in this study. Out of 131 participants in the control group, 11 (8.4%) had wound infection while out of 129 in the povidone iodine group, 4(3.1%) developed wound infection. The rate of wound infection in the control group (8.4%) was within the range of post-operative wound infections following caesarean section (0 to 20.5%) reported in a hospital survey conducted by Moir-Bussy and colleagues.37 In Nigeria, studies in Kano and Lagos reported rates within this range.38,39
Apart of ruptured membranes, other demographic, obstetric and surgical factors did not show any significant difference in development of wound infection between the control and povidone iodine groups. These were maternal age (p=560), educational level (p=0.154), ethnicity (p=0.476) and occupation (p= 0.930) of the participants. Others include booking status (p=0.310), parity (p=0.876), gestational age (p=0.282), number of vaginal examinations (p=0.770), duration of labour (p=0.476) and duration of caesarean section (p=0.533). Similar outcome was reported elsewhere.8,26,27,28 However, ruptured membranes with no treatment(in control group) prior to caesarean section was significantly associated with wound infection than in other subgroups 10(90.9%); OR(CI)=0.3(0.01-0.7), p=0.033. Similar observation has been reported in other studies .8, 27,28
Overall, there was significant reduction in the rate of endometritis and wound infection in the treatment group than in the control group in this study as was reported by other studies.8,
27,28 Risk of developing endometritis in the povidone iodine group was 3.1% and in the control group was 13.7%. Relative risk reduction of developing endometritis in povidone iodine group was 8%; and the number needed to treat (application of povidone iodine) to prevent one case
39
of endometritis was 9. Which means for every population treated, 11% will be prevented from having endometritis. Conversely, rate of developing wound infection in the povidone iodine group was 3.1% as against 8.4% in the control group with relative risk reduction of developing wound infection from 6.2% to 3.8%. Twenty persons needed to be treated in order to prevent one case of wound infection.These outcomes are significant and very important in our environment and other under developed countries with higher rate of post-caesarean section endometritis and wound infection.38,39,40 Coupled with the fact that puerperal sepsis is one of the common cause of maternal mortality in our environment (14.2%) with a high mortality index (79.3%) as was recorded in a nationwide study in Nigeria on maternal mortality and near misses by Oladapo OT et al.20
In addition, those who survive this infection may develop morbidities like local spread of infection to cause salpingitis, oophoritis, peritonitis, wound infection, pelvic abscess, septicaemia and spread to any organ or system.8,21,30 This results to delay from discharge, required to do more investigations and receive more antibiotic treatment, surgical re-exploration, inability to breast feed and take care of her new born and increase in economic burden.21,30 Long term complications that may occur include uterine synechia, pelvic adhesions, tubal factor infertility and chronic pelvic pain.8,21,30
This study has shown that, all of these complications can be reduced from the rate of 13.7%
(endometritis in the control group) to 3.1% (povidone iodine group) by one simple, safe and inexpensive procedure, notably, cleansing the vagina with 10% povidone iodine prior to emergency caesarean section. This is important in our low socio-economic environment with poorly equipped hospitals, fewer skilled workers, poverty and ignorance among the populace.
5.2 . Conclusion
Cleansing the vagina with povidone iodine prior to emergency caesarean section tended to reduce occurrence of endometritis in women who presented with ruptured membranes and prolonged labour (≥24hrs).
The procedure also reduced the occurrence of wound infection in women who presented with ruptured membranes.
40
None of the participants complained of any side effects or adverse reactions from the use of povidone iodine.
Because this study has shown that, antiseptic vaginal preparation with povidone iodine prior to emergency caesarean section does prevent post-caesarean endometritis and wound infection; null hypothesis has been rejected.
5.3 . Recommendation
Vagina should be cleansed with 10% povidone iodine prior to emergency caesarean sections to prevent post-operative endometritis and wound infection especially among women who presented with ruptured membranes and prolonged labour.
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Appendices
INFORMED CONSENT FORM
My name is Dr. Ketare Nathaniel. I am a senior registrar in the department of Obstetrics and Gynaecology in University of Abuja Teaching Hospital. I am conducting a research on antiseptic vaginal preparation using povidone iodine prior to caesarean section and its effect in preventing pelvic and wound infections. Its side effects such as local irritation are usually mild and very rare but I should be informed, if it occurs. I would appreciate your participation in this study. The research is designed to benefit the society by gaining new knowledge.
You will be required to answer some questions which might pertain to your health and personal life. However I shall contact you at delivery to inquire your experience during the period of delivery and 2 weeks thereafter.
48
Participation in this survey is voluntary and you can choose not to answer any individual question or all of the questions. However, I hope that you will participate in this survey since your views are very important. By signing this form it is taken that you have full understanding of the research and have given your informed consent for participation in the research.
Thank you very much for agreeing to participate in this survey. Whatever information you provide will be kept strictly confidential.
Signature of interviewer Date
Signature of participant Date
Hospital Number………..
Study identification Code ………
Patient phone number………..
PROFORMA
Vaginal preparation with antiseptic solution (povidone iodine) before caesarean section and effect on preventing post-operative infections at University of Abuja Teaching Hospital, Abuja, Nigeria.
Enrolment code ---
Bio data
1.Age in years [ ]18-23 [ ]24-29[ ]30-35[ ]>35
2. Ethnic group: 1= Ibo 2= Hausa 3= Yoruba 4= others (specify)--- 3 .Religion: 1=Islam 2=Christianity 3=Traditional 4=others (specify)...
4 .Educational level: 1= None 2=Primary 3= Secondary 4=Tertiary
49
5.Occupation: 1=Housewife 2=Civil servant 3=Student 4=Farmer 5=Others(specify)---
6. Marital status: 1= Married 2=single 3=divorce 4=widow.
7.Husband’s occupation: 1=Civil servant 2=Student 3=Farmer 4=Trader 5=Others(specify)---
Baseline assessment;
Booking status: Booked[ ], unbooked[ ] Gravidity/Parity ...
LMP [ ] EGA [ ] EDD [ ]
Previous relevant pregnancy outcome……….
Baseline examination Temparature ………°c Pulse rate………beats/min Baseline investigations
PCV……….%
Blood group………...
Cross matching of blood………..
Genotype…………...
Urinalysis………...
Pre-delivery condition [ ]emergency CS
patient in labour Yes=[ ] No=[ ] membranes intact Yes=[ ] No=[ ]
Number of VEs Nil= [ ] 1-3=[ ] ≥4=[ ] Duration of labour in hours <6[ ] 6 to<12[ ] 12to<18[ ] 18to<24[ ] ≥24[ ]
Intra-operative conditions
Estimated blood loss <1litre[ ]>1litre[ ]
50
Duration of surgery <2hours[ ]>2hours[ ] Puerperal events
Mother and baby will be followed up for 2 weeks and the following conditions will be noted.
Maternal
Endometritis……….
Wound infection………
Vaginal irritation/allergy………
Infant events
Admission into SCBU/Indication……….
Any side effect...………..………
ACTIVITY PLAN (Gant’s Chart)
Activity Dec.
2016
Feb.
2017
March.
2017-August 2017
Sept.
2017
Oct.
2017
Nov.
2017
Dec.
2017
April 2018
Submission of
proposal to College for approval
XX
Await response from college.
XX
Data collection XX