The efficacy of vitamin D combined with clomiphene citrate in ovulation induction in overweight women with polycystic ovary syndrome: a double blind, randomized clinical trial.

PURPOSE: The aim of this study was to assess the effect of vitamin D supplementation on ovulation rate in overweight subfertile women with PCOS undergoing ovulation induction. METHODS: This was a single center, parallel-groups, double-blind, and placebo-controlled randomized trial involving 186 eligible women undergoing induction of ovulation with clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily starting from the third day of menstrual cycle and for 5 days combined with either oral Vitamin D (ossofortin®, EVA PHARMA) 10,000 IU twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries) 1250 mg twice daily or to receive a placebo with calcium for three successive induction cycles. The vitamin D or placebo supplementation started 1 month before induction cycles (total four cycles). Cycles were monitored with ultrasound follicle tracking and mid-luteal serum progesterone measurement. The primary outcome was the ovulation rate after three induction cycles. RESULTS: The study was performed during the period between January 2018 and September 2018, Eighty six (92.5%) women in the treatment group and 73 (78.5%) in the control group had successful ovulation (p = 0.007). The absolute and relative risk reduction was 14% and 65% respectively. Biochemical and clinical pregnancy occurred in 61.3 and 50.5% in the treatment group, and in 49.5 and 39.8% in the control group (p = 0.105 and 0.141 respectively). CONCLUSION: In subfertile women with PCOS undergoing induction of ovulation, vitamin D supplementation significantly improved the ovulation rate; however, there was no effect on clinical or biochemical pregnancy.

Intrauterine Instillation of Tranexamic Acid in Hysteroscopic Myomectomy: A Double-Blind, Placebo-Controlled, Parallel-Group Randomized Clinical Trial.

STUDY OBJECTIVE: To evaluate the hemostatic effect of intrauterine instillation of tranexamic acid (TXA) with the distention medium during hysteroscopic myomectomy. DESIGN: Prospective, parallel-group, double-blind, placebo-controlled randomized clinical trial. SETTING: Early Cancer Detection Unit in Ain Shams University Maternity Hospital, Cairo, Egypt. PATIENTS: Eighty women with type 0 or I submucous myoma undergoing hysteroscopic myomectomy using unipolar resectoscope. INTERVENTIONS: The participants were randomly assigned to receive either 1 g of TXA for every 1000 mL of the distending medium (intervention group) or 10 mL of placebo (10 mL of 1.5% glycine) in the same form inside every 1000 mL of the distention medium. MEASUREMENTS AND MAIN RESULTS: The primary outcome was a change in hemoglobin level 24 hours after surgery compared with preoperative values, and the secondary outcomes were the surgeon's rating of intraoperative bleeding and the quality of operative view, the duration of surgery, the volume of injected media, intraoperative complications, and the completion of myomectomy in 1 procedure. The mean difference in hemoglobin level was 1.11 ±.58 g/dL in the TXA group and 1.46 ± 0.61 g/dL in the placebo group (p = .015). The quality of hysteroscopic view was better in the TXA group (p = .001), with good operative view in 23 (60.5%) cases in TXA vs 8 (20.5%) in the placebo group. The surgeon's rating of bleeding as excessive was reported in 1 (2.6%) case in the TXA group and in 9 (23.1%) cases in the placebo group. There was no difference between the groups regarding the duration of surgery, the volume of injected media, completion of myoma resection in 1 session, and intraoperative complications. Three cases of uterine perforation with the thermal loop were reported, and all were associated with poor operative field in the placebo group. CONCLUSION: Intrauterine instillation of TXA with the distention medium during hysteroscopic myomectomy resulted in a statistically significant decrease in hemoglobin level 24 hours after surgery, albeit with minimal clinical significance. TXA resulted in better visualization of the field throughout the procedure.

Agreement between transvaginal ultrasound and saline contrast sonohysterography in evaluation of cesarean scar defect.

OBJECTIVES: to assess the agreement between saline contrast sonohysterography (SCSH) and transvaginal sonography (TVS) in the evaluation of cesarean section scar defect (CSD) regarding its width, depth, and shape and also in assessing the anterior myometrium, and residual myometrium related to the scar. MATERIAL AND METHODS: a prospective study during the period between August 2017 and January 2018 was conducted in which 102 consecutive participants underwent primary cesarean section in Ain Shams University Maternity Hospital were assessed six weeks after CS to evaluate for CSD presence by using both SCSH and TVS. RESULTS: CSD could be detected only in 59.8% of women by TVS and 70.5% by SCSH with good agreement strength (Cohen kappa = 0.805). TVS was 84.72% sensitive and 100.00% specific in identifying CSD diagnosed by SCSH. The PPV, NPV, and accuracy of TVS were 100.00%, 73.17%, and 89.21%, respectively. The mean anterior myometrial thickness (AMT) did not differ when assessed by both TVS and SCSH, while the mean niche width was 2.56 ± 1.98 mm with SCSH compared to 2.17 ± 1.63 mm with TVS(r = 0.954), and its mean depth was 2.76 ± 2.02 mm for SCSH and 1.57 ± 1.51 mm in TVS(r = 0.812). The mean residual myometrium was 10.09 ± 2.74 mm in SCSH while was 11.18 ± 2.50 mm for TVS(r = 0.914) CONCLUSION: cesarean scar defects in non-pregnant women are better evaluated at SCSH than at unenhanced TVS as more defects detected by SCSH and better evaluation of its shape, borders and size.

Vaginal misoprostol before copper IUD insertion after previous insertion failure: a double-blind, placebo-controlled, parallel-group, randomised clinical trial.

Objective: The aim of the study was to assess whether vaginal administration of misoprostol before copper intrauterine device (IUD) insertion increased the success of the procedure among parous women with previous insertion failure. Methods: A single-centre, parallel-group, double-blind, placebo-controlled, randomised clinical trial was conducted at Ain Shams University Maternity Hospital, Cairo, Egypt, between October 2015 and August 2016. The study comprised 90 parous women undergoing TCu380A IUD insertion after a failed attempt. A computer-generated list of random numbers was used to assign participants to receive either misoprostol 200 µg or a placebo tablet, applied vaginally 10 h and 4 h prior to the second attempted IUD insertion, without ultrasound guidance. The primary outcome was the success of IUD insertion. Secondary outcomes were to establish the effect on insertion success of cervical dilation, cervical softening and previous mode of delivery. Results: Forty-two women (93.3%) in the misoprostol group and 24 women (53.3%) in the placebo group had a successful IUD insertion (p < .001). Cervical dilation was required in 24 women in the misoprostol group and 44 women in the placebo group. Misoprostol application significantly increased insertion success in women with previous caesarean delivery (p < .001) but did not affect insertion success in women with previous vaginal delivery (p = .481). Conclusion: Vaginal misoprostol before IUD insertion in parous women with previous insertion failure increased the rate of successful insertion, particularly in women with previous caesarean delivery.

Accuracy of the Manipal Cervical Scoring System for predicting successful induction of labour.

The Manipal Cervical Scoring System is an accurate and objective sonographic score that predicts the outcome of induced labour. The aim of the current study was to compare the performance of the Manipal Cervical Scoring System against the Bishop Score. A prospective study was conducted on 105 women underwent labour induction in Ain Shams University Hospital, Cairo, Egypt. Both scores were assessed pre-induction. Successful induction occurred in 78.09% of the cases. The area under the ROC curve (AUC) was of 0.940 (95% CI = 0.876 to 0.977; p value <.0001) for the Manipal Score and 0.863 (95% CI = 0.783-0.923; p value <.0001) for the Bishop Score. The Manipal Score >5 had a sensitivity of 91.5% and a specificity of 91.3%. While the Bishop score >4 had a sensitivity of 98.8% and specificity of 69.6% to predict the outcome of induced labour. The Manipal Cervical Scoring system is a better objective tool to predict the outcome of labour induction compared to the Bishop Score. However, other female and fetal characteristics, including body mass index (BMI) at gestation, gestational weight gain, occiput position and parity should be taken into consideration when performing labour induction. Impact statement What is already known on this subject? The ultimate fate of 20% of women having an induction of labour (IOL) is a Caesarean delivery. Thus, predicting the possible response to IOL before starting induction could guide clinicians to determine the efficacy of starting and/or continuing the induction process and in counselling women regarding the possible response to IOL. The main predictor for IOL outcome is based on the pre-induction cervical status which has been traditionally assessed by the Bishop Score. However, the Bishop Score remains subjective, thereby, associated with high rates of bias and several studies have demonstrated its poor predictive value for the outcome of induction. What do the results of this study add? Proposed use of ultrasound parameters that are equivalent to Bishop Score will be objective, reliable and reproducible method. It allows for patient re-evaluation by other obstetricians without the need for re-examination (thus decreasing exposing the patient to pain and anxiety). What are the implications of these findings for clinical practice and/or further research? According to WHO and FIGO, oral misoprostol (25 µg, 2-hourly) is recommended for induction of labour. This helps to decrease the discomfort of repeated vaginal examination and increases the women satisfaction with labour process, especially in women at higher risk of infection. Thus evaluating cervical status using an ultrasound cervical scoring system can similarly increase women's satisfaction with labour process. Our goal in the upcoming trial is to perform RCT comparing ultrasound versus Bishop in women undergoing IOL using oral misopristol regarding measures of satisfaction during labour in the parturient women.

The effect of alpha lipoic acid on uterine wound healing after primary cesarean section: a triple-blind placebo-controlled parallel-group randomized clinical trial.

PURPOSE: To investigate the effect of alpha lipoic acid (ALA) on uterine wound healing after primary cesarean section (CS). METHODS: A parallel-group, triple-blind, placebo-controlled randomized clinical trial was conducted in Ain Shams University Maternity Hospital, Cairo, Egypt, involving 102 women undergoing pre-labor primary CS. The participants were randomly assigned using a computer-generated list of random numbers to receive oral ALA or a placebo twice daily for 6 weeks after CS. Allocation to either group was in a 1:1 ratio by an independent statistician (not involved in the treatment or data collection). The primary outcome was the presence of CS defect and measuring its depth and width. Secondary outcomes were measurements of the anterior myometrial and residual myometrium thicknesses, healing ratio and the presence of intrauterine adhesions. Assessment was done using saline contrast sonohysterography. RESULTS: Twenty (39.2%) women in the treatment group and ten (19.6%) controls had no niche (P value = 0.03, 95% CI - 0.388, - 0.0037). The absolute and relative risk reduction of forming a niche was 19.61% and 24.39%, respectively. The number of women needed to treat was five to avoid one niche formation. ALA use was associated with gastrointestinal upset in only three participants; however, none of the women withdrew during the study. CONCLUSION: In women undergoing primary CS, the administration of ALA for 6 weeks postpartum improved uterine healing and decreased the incidence of scar niche.