The present study aimed at finding the outcomes of medical versus surgical management of incomplete abortion that included effectiveness, secondary outcomes and satisfaction level. In this study, out of the 50 participants enrolled in surgical arm, 96% (n=48) had successful evacuation of the uterus using MVA. Of those in the medical arm, 84% (n=42) had successful evacuation of the uterus. This meant that two patients on the surgical arm and eight patients on the medical arm had primary failure that required a second surgical method for evacuation of retained products of conception. This interpreted in a different way, is that 80% (n=8) of all those with primary failure were from medical arm and only 20% (n=2) were from the surgical arm. Of the two patients that were evacuated, both of them were uncooperative due to pain despite the cervical block and verbal reassurance. Also, both patients had previous uterine scar due to caesarean section. This made it difficult for the doctors to achieve complete evacuation in the first procedure. The patients were both stable after first evacuation but a trans-abdominal pelvic scan done after 48 hours showed retained products of conception exceeding 30 mls. Dilatation and Curettage was done after the initial MVA. This therefore meant that surgical method significantly reduces the risk of primary failure by 11.7% as compared to medical method (RRR=11.7%, p=0.043).
The effectiveness of surgical method on management of incomplete abortion has been studied in various parts of the world. In the present study, the effectiveness was 96%. This is generally a mild lower success rate of the method as compared to other previous studies by Shochet et al., (9) and Shokry et al., (10) that noted 100% success rate. The minimal difference between the current study and the previous studies may be explained by the differences in the surgical skills among the different healthcare providers for the different settings. The fact that KIUTH is a teaching hospital with majority of the attending doctors residents could explain the discrepancy. This has been shown to affect effectiveness of surgical management as surgical skill is a determining factor. Moreover, in Africa, surgical intervention by most of the population is considered as too invasive and most patients would be apprehensive to have the procedure which may lead to lack of cooperation and failure of the method (11).
The effectiveness of medical method in the present study was at 84% which was comparable to a study done in Yemen Shuaib et al., (12) that had an effectiveness of 83% using misoprostol 400µg in the posterior fornix and 200µg 4 hourly for 3 doses and review was done after 7 days. It was however found to be less as compared to a previous study done in India where an effectiveness of 97% using misoprostol 600µg orally and review after 3 days was reported Bhadra et al., (13). The current effectiveness was higher than one reported by in Senegal (50%-60%) using misoprostol 400µg as a single dose and review done after 7 days (14). The difference in the effectiveness can be explained by the brand of misoprostol used and the route of administration used with vaginal and sublingual route considered superior to oral route. Also, the higher the dose, the more the effectiveness (15). Apart from this, different definition of success including how many days after initiation of treatment the patient waits for the method to be declared a failure and the volume of retained products that is considered unsuccessful was different. The longer the duration and the more the volume, the higher the success rate (15)
The present study showed that surgical management of first trimester incomplete abortion by MVA is more effective than medical management of first trimester abortion using misoprostol 800 microgram in the posterior fornix 6 hourly with a maximum of 3 doses and reviewed after 48 hours. This was consistent with several other studies done in South Sudan with success rates of 100% and 93.5% for surgical and medical methods respectively (16). Other studies have shown higher effectiveness with surgical method as compared to medical method although these were not statistically significant. For example Dastgiri et al., (17) in Iran and Panta et al., (18) in Nepal with effectiveness of 97% and 95% for surgical and medical management respectively. In East Africa, recent studies are missing with the latest studies being in Uganda with effectiveness of 96.3% versus 91.5% with a review after one week (19) and Tanzania with effectiveness of 100% versus 99% for surgical and medical management respectively with a review after two weeks (20). The higher effectiveness of medical method in Tanzania and Uganda studies is probably due to prolonged duration that the participants waited before a method was declared a failure. However, a study done in India showed a higher success rate of 97% in medical management as compared to 95% for surgical management using single dose 600µg vaginally and review after 2 weeks (21). The higher effectiveness of medical management in the study done in India can be explained by the differences in the brand of misoprostol used and the definition of success which was reviewed after 15 days as compared to the present study of which review was after 48 hours only. The longer the duration you wait to declare medical method as failure the higher the success rates (15). Therefore, given the higher effectiveness of surgical method including the need for surgical method in case of failure of the medical method, it is mandatory to train as many personnel as possible and provide this service to most, if not all, health facilities because if done properly, it is very promising.
Comparative secondary outcomes encountered when first trimester incomplete abortion is managed using medical or surgical methods.
In the present study, the mean length of admission to the hospital was longer in medical 2.18 days (sd=0.39) than surgical 2.04 days (sd=0.04) arm that was statistically significant (p=0.03).As regards bleeding duration, most of the patients (54%) in medical arm had moderate and severe bleeding in terms of hours of bleeding (more than 7 hours of bleeding) while most of those in surgical arm (94%) reported mild bleeding that lasted less than 6 hours. This was statistically significant. In this present study, majority of the participants (64%) in medical arm experienced mild pain (n=32) while 78% (n=39) of those managed surgically reported severe levels of pain that was statistically significant. 90% (n=45) of those who underwent medical management would recommend the method while only 50% (n=25) on surgical method would (p<0.001). Those randomized in the medical arm had increased incidences of fever, chills, nausea that was statistically significant as compared to surgical method. Although there were more participants having syncope, dizziness, headache, and requiring blood transfusion in the surgical arm, this was not statistically significant. Only 1 case of infection was reported in the surgical arm and there was no case of trauma to genito-urnary tract.
The present study showed that the participants on medical arm had longer stay in the hospital than their counterparts in surgical arm. In our study, this was explained by the fact that as compared to surgical management, 80% of the patients who had failure of the method were from medical arm while only 20% were from surgical arm. This therefore meant that they had to be kept in hospital for 1 more day as compared to those who had expulsion of all retained products of conception. The other possible explanation was that because of prolonged bleeding, participants in medical method had to be kept in the ward till the bleeding was minimal. This present study findings are similar to a study done in chad (16) and Nigeria (22) which showed that surgical management required less hospital stay (less than 6 hours) as compared to medical management (more than 12 hours). This was due to immediate completion of uterine evacuation with surgical management. This therefore means that in patients on medical management there is strict need for follow up to confirm completion of abortion and if need be re-evacuation and monitoring bleeding. Health providers need to Emphasize and judge patient’s ability to come for follow up before initiating medical management.
The present study demonstrated that bleeding in surgical arm was of a shorter duration as compared to medical arm. The prolonged duration of bleeding in medical management was probably associated with prolonged period before complete expulsion of products of conception. This is because for bleeding to stop, all the products of conception have to be evacuated. This would also explain why surgical management had few hours of bleeding with most of them reporting stoppage of active bleeding immediately after completion of the procedure. Of importance to note is that although surgical management had few hours of bleeding, most of the symptoms associated with loss of excessive blood like syncope, dizziness, severe headache and blood transfusion were more common in the surgical arm. This is in agreement with previous study in middle East where bleeding duration in medical was more than in surgical management with all participants having some form of bleeding within the first 24 hours of which after 24 hours, no participants in surgical reported bleeding (23). Another study done in Nepal showed that 91.6% of participants managed medically had bleeding while none in surgical management had bleeding after evacuation (18). The reason why this symptoms of blood loss are common in the surgical arm than medical arm is that in surgical arm, there is sudden excessive loss of blood unlike in medical arm where bleeding is not more than menstrual flow (24). It is therefore paramount to have surgical procedure done in units that have access to some form of blood transfusion services and during the procedure to have capability to resuscitate patients in terms of airway, breathing and circulation. Proper training on how to carry out the procedure is a must to avoid excessive bleeding. Use of oxytocin and other drugs that cause uterine contractions post evacuation should also be emphasized.
The present study showed that majority 64.0% (n=32) of the patients in the medical arm reported mild pain while the majority 78.0% (n=39) in surgical arm reported severe pain that was statistically significant. This was consistent with findings in a study done in Nepal where 77% of the patients managed surgically reported severe pain (18). Another study in India also showed that up to 98% of patients managed surgically experienced excruciating pain while only 28% of those managed medically reported pain that was cramp like in nature (21). According to the same study, the pain during MVA can be so severe to cause vasovagal syncope that may lead to irreversible shock if not rectified early as it was experienced in 1 of the participants in the same study. The excessive pain in surgical management in our study and other studies quoted is due to the fact that MVA involves mechanical evacuation as opposed to medical of which evacuation is due to uterine contractions. However, a study done at N’Djamena hospital in Chad showed no statistically significant difference between the pain level experienced in use of misoprostol or surgical evacuation of the uterus (16). This was probably due to the fact that although surgical method is associated with high intensity of pain that is short lasting, medical method is associated with low intensity pain but it is prolonged. According to the present study, pain control especially in the patients managed surgically is paramount to avoid vasovagal syncope. Excessive pain may also reduce patient’s satisfaction with surgical method and may lead to lack of cooperation that may result in genito-urinary tract injury, incomplete evacuations and other adverse effects. In our study, we used para cervical block and verbal assurance during the procedure but still had patients reporting severe pain. Therefore, more analgesia like a systemic opioid or conscious sedation should be used as an add-on to para cervical block to reduce the pain level. Another important factor is to use verbal reassurance and pre procedure counseling on what to expect during the procedure that may help in reducing the pain level.
The present study determined that 90% (n=45) of those managed medically would recommend the method to other patients while only 50% (n=25) would recommend surgical evacuation. The above finding is consistent with a study done in Tanzania where 95% of participants would recommend medical method while only 75% would recommend surgical method (20). Other studies have found that surgical is preferred to medical (16), while others report no statistically significant difference between the two methods (23). The main reason why participants did not recommend surgical method was because of increased pain. Other reasons included invasive nature of surgical method, use of anaesthesia, fear of trauma to genito-urinary tract and negative psychological perceptions. However participants that recommended surgical method did so mainly because of immediate evacuation with higher success rate and less bleeding. Participants who preferred medical method reported that the main reason was not only because of less pain, but also because of the less nature of invasiveness, no anaesthesia and the general acceptability of drug use as compared to surgery. The main reason why participants did not prefer medical method was because of the failure of the method with all the 8 participants who had primary failure opting for alternative method. Other reasons included prolonged hospital stay and prolonged bleeding. These same reasons for and against medical and surgical intervention are similar to findings of analyzed studies by (25). With this present study findings, pain management is an important factor in determining recommendation of a given method and so pain levels have to be suppressed to ensure patients recommendation. Pre-procedure counseling should also be given to every patient.
This current study showed higher incidences of fever, chills and nausea in medical arm as compared to surgical arm. Fever in 38% versus 6% (p<0.001), chills in 38% versus 10% (p=0.001) and nausea in 22% versus 8% (p=0.047) for medical versus surgical management respectively which were all significant. Finding is similar to a study done in Vietnam where 82.7% of patients managed medically reported this effects but they were self-limiting (26). A study done in Chad showed the same findings as regards to fever, chills and nausea (16). Even though this may be constitutional symptoms, they may point towards an infection especially fever. In the present study, this was mainly due to side effects of misoprostol. This side effects were however mild and self-limiting and no extra medication apart from those on the research protocol were added to treat them as demonstrated by earlier studies (26). The presence of these side effects did not affect the participants’ recommendation of the method. This knowledge should be known to all providers and should be passed to patients undergoing medical management. This will ensure no anxiety on the patient’s side when these self-limiting side effects arise and avoid irrelevant medical tests and costs. However, if there is any sign of infection associated with these symptoms then urgent intervention should be instituted.
In the present study, only 1 participant developed infection in those assigned to surgical management and none in medical management. This was a 24 year old para 1+0 gravida 2 at 11 weeks of amenorrhea who presented with incomplete abortion but had stayed home for 4 days bleeding hoping for spontaneous abortion and only came to hospital on the 5th day. However on arrival, she did not have any signs of infection and was enrolled in the study. 24 hours after MVA she was noted to have signs of endometritis but was successfully treated on intravenous antibiotics. Prolonged retention of products of conception is a risk factor for infection (27). This most likely played a role in this patient. Generally no consensus has been found between which method has more risks for infection than the other (28). Due to the invasive nature of surgical management some studies have found higher infection rates in this group like a study done in Mulago hospital in Uganda (19). The study in Mulago hospital reported ten incidences of infection and this might be explained by the fact that unlike KIUTH, Mulago hospital is the National Referral Hospital. Other studies argue that longer induction-abortion time may lead to higher occurrence of infections (12). There are other factors that determine infection rates including; surgical technique, antiseptic used, use of prophylactic antibiotics and clients immune system (29). In the present study doxycycline 100mgs orally as a single dose or azithromycin 1gram orally single dose was effective as prophylactic antibiotic. To avoid infections, providers should stick to standard operating procedures, maintain aseptic techniques, use prophylactic antibiotics and empower patients to seek medical attention with the earliest warning signs like increasing lower abdominal pain and offensive vaginal discharge.
The present study did not register any trauma to the genito-urinary tract in both groups which was contrary to a study conducted in Mulago hospital in Uganda where five patients had trauma to the cervix although none of them required more than one suture knot on the cervix (19). Generally, surgical methods have higher rates of trauma (about 5.6%) (30) as compared to medical management that is generally insignificant. With medical method however, rupture of uterus may occur if larger doses are used in patients with previous uterine scars (30). Therefore provided proper training is given, surgical method can be carried out without any trauma. Also, periodic refresher courses would help review and update knowledge on surgical technique. Patients with previous uterine scars should be assessed and benefits against risks weighed before initiating misoprostol as this can lead to uterine rupture. As suggested by Nouhjah et al., (31), initiation should only be done at centers where monitoring and comprehensive care is available in this group of patients.
Comparative levels of satisfaction between medical and surgical management of first trimester incomplete abortion
In the present study 50 participants were randomized in each arm. Most of the participants 48% (n=24) in medical management reported to be very satisfied while only the minority 2% (n=1) in surgical management reported to be very satisfied. Although this was not statistically significant (p=0.07), the difference in numbers was absolute. Those who reported to be somewhat satisfied with each method were 26% and 38% for medical and surgical management respectively. 30 participants which is more than half of the patients in surgical arm reported to be dissatisfied with surgical management (n=21 for somewhat dissatisfied and n=9 for very dissatisfied). Only 13 participants in the medical arm reported dissatisfaction (n=10 for somewhat dissatisfied and n=3 for very dissatisfied). In this study, although the most number of participants in medical arm were satisfied and the opposite was true for surgical method, there was no statistical significance between the two groups’ satisfaction level. This is in line with a study done in Uganda (19). The study in Uganda reported that the reasons why participants were satisfied with medical management were because of less pain, effectiveness, non-invasiveness and lack of anaesthesia use. It also reported participants were satisfied with surgical method because of high effectiveness, short duration of treatment, less hours of bleeding and reduced hospital stay. This was in keeping with the present study. A previous study by Shochet and colleagues also found similar outcomes regarding satisfaction (9). Other earlier studies found more satisfaction levels with surgical management as compared to medical management (23). The reason why participants were more satisfied with surgical method was because of high effectiveness, short duration of treatment and shorter duration of bleeding. Some studies have also found more satisfaction in medical arm 84% as compared to only 16% in surgical arm (26). Some of the reasons given for this was that medical management had less pain, high effectiveness, lack of surgery and lack of anaesthesia (26). Patients should therefore be offered a method that gives maximum satisfaction as this will encourage health seeking behaviour and avoid unsafe abortion services which will lead to reduced abortion related complications.