George Uchenna Eleje

Methods for assessing pre‐induction cervical ripening

Background Induction of labour is the artificial initiation of labour in a pregnant woman after the age of fetal viability but without any objective evidence of active phase labour and with intact fetal membranes. The need for induction of labour may arise due to a problem in the mother, her fetus or both, and the procedure may be carried out at or before term. Obstetricians have long known that for this to be successful, it is important that the uterine cervix (the neck of the womb) has favourable characteristics in terms of readiness to go into the labour state. Objectives To compare Bishop score with any other method for assessing pre‐induction cervical ripening in women admitted for induction of labour. Search methods We searched the Cochrane Pregnancy and Childbirth Groups Trials Register (31 March 2015) and reference lists of retrieved studies to identify randomised controlled trials (RCTs). Selection criteria All RCTs comparing Bishop score with any other methods of pre‐induction cervical assessment in women admitted for induction of labour. Cluster‐RCTs were eligible for inclusion but none were identified. Quasi‐RCTs and studies using a cross‐over design were not eligible for inclusion. Studies published in abstract form were eligible for inclusion if they provided sufficient information. Comparisons could include the following. 1. Bishop score versus transvaginal ultrasound (TVUS). 2. Bishop score versus Insulin‐like growth factor binding protein‐1 (IGFBP‐1). 3. Bishop score versus vaginal fetal fibronectin (fFN). However, we only identified data for a comparison of Bishop score versus TVUS. Data collection and analysis Two review authors independently assessed the trials for inclusion, extracted the data and assessed trial quality. Data were checked for accuracy. Main results We included two trials that recruited a total of 234 women. The overall risk of bias was low for the two studies. Both studies compared Bishop score withTVUS. The two included studies did not show any clear difference between the Bishop score and TVUS groups for the following main outcomes: vaginal birth (RR 1.07, 95% CI 0.92 to 1.25, moderate quality evidence), caesarean delivery (RR 0.81, 95% CI 0.49 to 1.34, moderate quality evidence), neonatal admission into neonatal intensive care unit (RR 1.67, 95% CI 0.41 to 6.71, moderate quality evidence). Both studies only provided median data in relation to induction‐delivery interval and reported no clear difference between the Bishop and TVUS groups. Perinatal mortality was not reported in the included studies. For the reviews secondary outcomes, the need for misoprostol for cervical ripening was more frequent in the TVUS group compared to the Bishop score group (RR 0.52, 95% CI 0.41 to 0.66, two studies, 234 women, moderate quality evidence). In contrast, there were no clear differences between the Bishop scope and TVUS groups in terms of meconium staining of the amniotic fluid, fetal heart rate abnormality in labour, and Apgar score less than seven. Only one trial reported median data on the induction‐delivery interval and induction to active phase interval, the trialist reported no difference between the Bishop group and the TVUS group for this outcome. Neither of the included studies reported on uterine rupture. Authors conclusions Moderate quality evidence from two small RCTs involving 234 women that compared two different methods for assessing pre‐induction cervical ripening (Bishop score and TVUS) did not demonstrate superiority of one method over the other in terms of the main outcomes assessed in this review. We did not identify any data relating to perinatal mortality. Whilst use of TVUS was associated with an increased need for misoprostol for cervical ripening, both methods could be complementary. The choice of a particular method of assessing pre‐induction cervical ripening may differ depending on the environment and need where one is practicing since some methods (i.e. TVUS) may not be readily available and affordable in resource‐poor settings where the sequelae of labour and its management is prevalent. The evidence in this review is based on two studies that enrolled a small number of women and there is insufficient evidence to support the use of TVUS over the standard digital vaginal assessment in pre‐induction cervical ripening. Further adequately powered RCTs involving TVUS and the Bishop score and including other methods of pre‐induction cervical ripening assessment are warranted. Such studies need to address uterine rupture, perinatal mortality, optimal cut‐off value of the cervical length and Bishop score to classify women as having favourable or unfavourable cervices and cost should be included as an outcome.

Palliative interventions for controlling vaginal bleeding in advanced cervical cancer.

BACKGROUNDnCervical cancer is the second most common cancer among women worldwide, with around 500,000 new diagnoses and 273,000 deaths per year. However, incidence and stage at diagnosis vary greatly between geographic areas and are largely dependent on the availability of a robust population screening programme. For example, in Nigeria, advanced-stage disease at presentation is common (86% to 89.3% of new cases), whereas in the UK, only 21.9% of women present with International Federation of Gynaecology and Obstetrics (FIGO) stage II+ disease. Women with advanced cancer of the cervix often need palliation for distressing symptoms, such as vaginal bleeding. Vaginal bleeding can be life threatening in advanced disease, with an incidence ranging from 0.7% to 100%. Bleeding is the immediate cause of death in 6% of women with cervical cancer and its management often poses a challenge.Thus, vaginal bleeding remains a common consequence of advanced cervical cancer. Currently, there is no systematic review that addresses palliative interventions for controlling vaginal bleeding caused by advanced cervical cancer. A systematic evaluation of the available palliative interventions is needed, to inform decision-making.nnnOBJECTIVESnTo evaluate the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy for palliative treatment of vaginal bleeding in women with advanced cervical cancer.nnnSEARCH METHODSnWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 2, 2015; the Cochrane Gynaecological Cancer Group Trials Register; MEDLINE from 1980 to March week 3, 2015 and EMBASE from 1980 to February week 12, 2015. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles and contacted experts in the field. We handsearched citation lists of relevant studies.nnnSELECTION CRITERIAnWe searched for randomised and non-randomised comparative studies that evaluated the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy techniques for palliative treatment of vaginal bleeding in women with advanced cervical cancer (with or without metastasis), irrespective of publication status, year of publication or language in the review.nnnDATA COLLECTION AND ANALYSISnTwo review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no studies were identified for inclusion and, therefore, we analysed no data.nnnMAIN RESULTSnThe search strategy identified 1335 unique references of which 1160 were excluded on the basis of title and abstract. We retrieved the remaining 22 articles in full, but none satisfied the inclusion criteria. We identified only observational data from single-arm studies of women treated with formalin-soaked packs, interventional radiology or radiotherapy techniques for palliative control of vaginal bleeding in women with cervical cancer.nnnAUTHORS CONCLUSIONSnThere is no evidence from controlled trials to support or refute the use of any of the proposed interventions compared with radiotherapy. Therefore, the choice of intervention will be based on local resources. Radiotherapy techniques for managing vaginal bleeding are not readily available in resource-poor settings, where advanced cases of cervical cancer are predominant. Thus, this systematic review identified the need for a randomised controlled trial assessing the benefits and risks of palliative treatments for vaginal bleeding in women with advanced cervical cancer.

Hepatitis B immunoglobulin during pregnancy for prevention of mother-to-child transmission of hepatitis B virus

BACKGROUNDnHepatitis is a viral infection of the liver. It is mainly transmitted between people through contact with infected blood, frequently from mother to baby in-utero. Hepatitis B poses significant risk to the fetus and up to 85% of infants infected by their mothers at birth develop chronic hepatitis B virus (HBV) infection. Hepatitis B immunoglobulin (HBIG) is a purified solution of human immunoglobulin that could be administered to the mother, newborn, or both. HBIG offers protection against HBV infection when administered to pregnant women who test positive for hepatitis B envelope antigen (HBeAg) or hepatitis B surface antigen (HBsAg), or both. When HBIG is administered to pregnant women, the antibodies passively diffuse across the placenta to the child. This materno-fetal diffusion is maximal during the third trimester of pregnancy. Up to 1% to 9% infants born to HBV-carrying mothers still have HBV infection despite the newborn receiving HBIG plus active HBV vaccine in the immediate neonatal period. This suggests that additional intervention such as HBIG administration to the mother during the antenatal period could be beneficial to reduce the transmission rate in utero.nnnOBJECTIVESnTo determine the benefits and harms of hepatitis B immunoglobulin (HBIG) administration to pregnant women during their third trimester of pregnancy for the prevention of mother-to-child transmission of hepatitis B virus infection.nnnSEARCH METHODSnWe searched the The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, Science Citation Index Expanded (Web of Science), SCOPUS, African Journals OnLine, and INDEX MEDICUS up to June 2016. We searched ClinicalTrials.gov and portal of the WHO International Clinical Trials Registry Platform (ICTRP) in December 2016.nnnSELECTION CRITERIAnWe included randomised clinical trials comparing HBIG versus placebo or no intervention in pregnant women with HBV.nnnDATA COLLECTION AND ANALYSISnTwo authors extracted data independently. We analysed dichotomous outcome data using risk ratio (RR) and continuous outcome data using mean difference (MD) with 95% confidence intervals (CI). For meta-analyses, we used a fixed-effect model and a random-effects model, along with an assessment of heterogeneity. If there were statistically significant discrepancies in the results, we reported the more conservative point estimate. If the two estimates were equal, we used the estimate with the widest CI as our main result. We assessed bias control using the Cochrane Hepato-Biliary Group suggested bias risk domains and risk of random errors using Trial Sequential Analysis (TSA). We assessed the quality of the evidence using GRADE.nnnMAIN RESULTSnAll 36 included trials originated from China and were at overall high risk of bias. The trials included 6044 pregnant women who were HBsAg, HBeAg, or hepatitis B virus DNA (HBV-DNA) positive. Only seven trials reported inclusion of HBeAg-positive mothers. All 36 trials compared HBIG versus no intervention. None of the trials used placebo.Most of the trials assessed HBIG 100 IU (two trials) and HBIG 200 IU (31 trials). The timing of administration of HBIG varied; 30 trials administered three doses of HBIG 200 IU at 28, 32, and 36 weeks of pregnancy. None of the trials reported all-cause mortality or other serious adverse events in the mothers or babies. Serological signs of hepatitis B infection of the newborns were reported as HBsAg, HBeAg, and HBV-DNA positive results at end of follow-up. Twenty-nine trials reported HBsAg status in newborns (median 1.2 months of follow-up after birth; range 0 to 12 months); seven trials reported HBeAg status (median 1.1 months of follow-up after birth; range 0 to 12 months); and 16 trials reported HBV-DNA status (median 1.2 months of follow-up; range 0 to 12 months). HBIG reduced mother-to-child transmission (MTCT) of HBsAg when compared with no intervention (179/2769 (6%) with HBIG versus 537/2541 (21%) with no intervention; RR 0.30, TSA-adjusted CI 0.20 to 0.52; I2 = 36%; 29 trials; 5310 participants; very low quality evidence). HBV-DNA reduced MTCT of HBsAg (104/1112 (9%) with HBV-DNA versus 382/1018 (38%) with no intervention; RR 0.25, TSA-adjusted CI 0.22 to 0.27; I2 = 84%; 16 trials; 2130 participants; low quality evidence). TSA supported both results. Meta-analysis showed that maternal HBIG did not decrease HBeAg in newborns compared with no intervention (184/889 (21%) with HBIG versus 232/875 (27%) with no intervention; RR 0.68, TSA-adjusted CI 0.04 to 6.37; I2 = 90%; 7 trials; 1764 participants; very low quality evidence). TSA could neither support nor refute this observation as data were too sparse. None of the trials reported adverse events of the immunoglobulins on the newborns, presence of local and systemic adverse events on the mothers, or cost-effectiveness of treatment.nnnAUTHORS CONCLUSIONSnDue to very low to low quality evidence found in this review, we are uncertain of the effect of benefit of antenatal HBIG administration to the HBV-infected mothers on newborn outcomes, such as HBsAg, HBV-DNA, and HBeAg compared with no intervention. The results of the effects of HBIG on HBsAg and HBeAg are surrogate outcomes (raising risk of indirectness), and we need to be critical while interpreting the findings. We found no data on newborn mortality or maternal mortality or both, or other serious adverse events. Well-designed randomised clinical trials are needed to determine the benefits and harms of HBIG versus placebo in prevention of MTCT of HBV.

Effectiveness of antenatal perineal massage in reducing perineal trauma and post‐partum morbidities: A randomized controlled trial

The study aimed to evaluate the effectiveness of antenatal perineal massage (APM) in reducing perineal trauma and post‐partum morbidities.

Response to Letter to ‘Effectiveness of antenatal perineal massage in reducing perineal trauma and postpartum morbidities: A randomized controlled trial’: Letter to the Editor

We would like to thank Levina and Rottenstreicha for their interests in our study: Effectiveness of Antenatal Perineal Massage in Reducing Perineal Trauma and Postpartum Morbidities: A Randomized Controlled Trial and wish to respond to their concerns as follows: First, level of compliance was 100% and was implied in our study: ‘Participants were asked to maintain daily records of performance of antenatal perineal massage (APM) and were seen weekly to review their records and reinforce compliance.’ Those who did not comply strictly were excluded. Sample size calculated was based on the primary outcome measure. Wide confidence intervals obtained in some secondary outcome measures suggest that a larger sample size would have improved study’s precision and external validity as stated in study’s limitations. Second, we used an anal incontinence (AI) questionnaire which was used in recently published study. This was because there is yet a universally accepted validated questionnaire for AI unlike urinary incontinence (UI). Our study was limited to 3 months follow up in view of anticipated huge loss if follow up had extended beyond. Third, the only indication for episiotomy in our study was ‘impending/threatening spontaneous perineal tears (SPTs).’ We agree that third and fourth degree SPTs are associated with morbidity, however, they are indicators of poorly conducted and neglected second stage labor which episiotomy aims to avert. This explains absence of third and fourth degree SPTs in our study. The first and second SPTs were similar in both groups since episiotomy was only indicated when skilled birth attendants observed impending/threatening SPTs. The obstetric care providers were blinded to participants’ study groups and study’s objectives. Finally, the quoted Cochrane review concluded that APM was associated with reduction in incidence of perineal trauma, less risk of episiotomy, and no differences in incidence of first, second, third and fourth degree SPTs. These findings were similar to our study. On issue of UI and AI, only one out of four studies included in Cochrane review assessed for incidence of UI and AI. Our study agreed with Cochrane review that there was no difference in incidence of UI and fecal incontinence. Although the review observed lack of association with flatus incontinence contrary to our study, authors of Cochrane review called for caution in interpretation because of very small frequencies observed. In fact, they suggested for more studies in this direction as evidence was weak. This was one of the justifications for our study. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

Adjuvant laparoscopy for primary amenorrhoea

Introduction: Menstruation has long been an imperative societal indicator of female sexual development. Its absence is an important gynaecological problem requiring expert and adjuvant evaluation. Laparoscopy therefore offers a vital and invaluable means to the gynaecologist, in his quest for the accurate and genuine cause of primary amenorrhoea, in addition to clinical assessment and certain biochemical investigations. Cases: We report a case series involving seven cases of primary amenorrhoea that presented in Life Institute For Endoscopy Limited, Nnewi (private specialist gynaecological endoscopy centre) and had laparoscopy evaluation between February 2006 and January 2011(a six –year period). They were between the ages of 16 and 30 years with a mean age of 24.86 years. Three were married and had fertility challenge while four were still single. Two were diagnosed with ovarian agenesis, two with ovarian dysgenesis, and one each with mullerian duct dysgenesis and agenesis while one patient had a combination of mullerian duct dysgenesis and ovarian agenesis. Conclusion: Primary amenorrhoea remains a serious gynaecological concern. Laparoscopy evaluation as shown in these cases is an adequate and invaluable evaluation to unravel the anatomical cause of this anomaly and even propose possible line of treatment. Correspondence to: George Uchenna Eleje, Department of Obstetrics and Gynecology, Faculty of Medicine, College of Health Sciences, Nnamdi Azikiwe University, Nnewi Campus, PMB 5025, Nnewi, South-east, Nigeria; Effective Care Research Unit, Nnamdi Azikiwe University, Nnewi Campus, Nigeria, Tel: +2348068117444; E-mail: georgel21@yahoo.com

Successful pregnancy following refusal of laparoscopy but acceptance of hydrotubation-only procedure for bilateral tubal blockade

Background: Hydrotubation is the trans-cervical flushing of fluid through the fallopian tubes, commonly used in combination with laparoscopy for diagnostic purposes to determine the tubal patency in infertility investigation. Hydrotubation-only procedure can be done in women that refuse diagnostic laparoscopy. Case presentation: In this study, a case of 27-year-old nullipara was reported who presented to the Hospital with a history of inability to conceive. Investigations done prior to presentation to this facility included a hormonal profile which was indicative of hyperprolactinaemia. She also came in with a hysterosalpingogram which showed left cornual tubal blockage. The right tube was very poorly outlined and ended blindly with no peritoneal spill. The husband’s seminalysis was well within normal limits. She refused consent for laparoscopy but not hydrotubation. Following multiplehydrotubation, she had successful pregnancy and subsequently achieved a live birth. Conclusion: We report a case of pregnancy resulting from multiple hydrotubations. Two radiologists and a gynaecologist separately had discussed with this medical professional couple the result of the hysterosalpingography that showed bilateral tubal occlusion and they opted for hydrotubation-only procedure with resultant live birth. Correspondence to: George Uchenna Eleje, Department of Obstetrics and Gynecology, Faculty of Medicine, College of Health Sciences, NnamdiAzikiwe University, Nnewi Campus, PMB 5025, Nnewi, South-East, Nigeria. Tel: +2348068117444; E-mail: georgel21@yahoo.com