Effect of Hydrotubation in Unexplained Infertility â€“ A Randomized Controlled Trial

Unexplained infertility is a major gynecological problem with complex etiolgy. Partial tubal blockage with inflammatory reaction and thick mucus plugs in fallopian tubes and cervix is one of the likely causes in such cases. This study is based on the hypothesis that women having unexplained infertility could be helped by transcervical flushing of fluid through the fallopian tubes which would remove reversible blocking factors and help in achieving pregnancy.Objective:Â Â To compare the outcome of hydrotubation in unexplained infertility in clomiphene citrate stimulated cycles with control group (no Hydrotubation).Setting:Â Â Infertility Centre of a Public Sector Hospital.Study Design:Â Â A two years Prospective randomized controlled trial from Jan 2014 to Dec 2015.Method:Â Â 128 women participated in the study. Participants were divided into study and control group with 64 members in each group. Ovulation induction was done with clomiphene citrate in all the participants and confirmed by ovulation detection strips and follicular tracking on Ultrasonography. 50 cc cocktail of inject-ion (inj.) kanamycin 1 gm, inj. hydrocortisone and normal saline was injected transcervically in study group for three consecutive days from the next day after end of menstruation. No hydrotubation was done in control group. Main outcome measures were number of conceptions within next 3 cycles and complications of hydrotubation.Results:Â Â In hydrotubation group, 20 women conceived. Out of these, 14 women conceived in the same cycle in which hydrotubation was done while 6 pregnancies occurred in subsequent cycle. 4 pregnancies occurred in the control group. Complications of hydrotubation were mild abdominal pain (59 women), vomiting (49 women) and Per vaginum bleeding (18 women). There were significantly more pregnancies in women who experienced right shoulder tip pain after the procedure.Conclusion:Â Â In women with unexplained infertility, tubal hydration can increase conception rate and decrease the time to achieve pregnancy.Â

Download Full-text

The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0245 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Asieh Mehdipour ◽

Parvin Abedi ◽

Somayeh Ansari ◽

Maryam Dastoorpoor

Keyword(s):

Randomized Controlled Trial ◽

Postmenopausal Women ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Moderate Depression ◽

Before And After ◽

The Mean ◽

And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

Download Full-text

Effect of Sildenafil in Endometrial Ripening with Induction of Ovulation by Clomiphene Citrate in Polycystic Ovarian Syndrome; Double Blinded; Randomized Controlled Trial

Women Health Care and Issues ◽

10.31579/2642-9756/077 ◽

2019 ◽

Vol 2 (3) ◽

pp. 01-10

Author(s):

Dalia Mohammed Mohammed El-Khaldy ◽

Mohamed Saeed Khallaf ◽

Ahmed Mohamed Nour Eldin Hashad ◽

Ibrahim Shazly Mohamed Amen Elshazly

Keyword(s):

Randomized Controlled Trial ◽

Polycystic Ovarian Syndrome ◽

Controlled Trial ◽

Clomiphene Citrate ◽

Clinical Pregnancy ◽

Sildenafil Citrate ◽

Control Group ◽

Induction Of Ovulation ◽

Randomized Controlled ◽

Ovarian Syndrome

Back ground: World Health Organization (WHO) defines infertility as a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse. Worldwide, 8 to 12 percent of couples experience fertility problems. Causes of infertility in women were as follows: menstrual disorders (disorders of cycle length and flow) 62.6%, diseases (obesity, thyroid diseases, diabetes) 58.7%, impaired ovulation (hormonal disorders, oligoovulation and anovulation) 50.3%, uterine causes 16.7%, tubal factor 15.4%, and cervical causes 7.9%. In the male factor fertility there was semen abnormalities (44.6%), genetic factors (29.8%), anti-spermatogenesis agents (11%), and vascular disorders (17.2%). Aim of the Study: The purpose of this study is to evaluate the effect of sildenafil in endometrial ripening with induction of ovulation by clomiphene citrate in polycystic ovarian syndrome. Patients and methods: It is a randomized controlled trial on 65 infertile women with polycystic ovarian syndrome; patients were randomly divided into two equal groups. In control group, 31 patients were given oral sildenafil, one tablet every 12 hrs. From 2nd day of the cycle till 12th day and clomiphene citrate, one tablet every 12 hours, for 5 days from 3rd day of the menstrual cycle. In study group, 34 patients were given oral placebo, one tablet every 12 hrs. From 2nd day of the cycle till 12th day and clomiphene citrate, one tablet every 12 hours, for 5 days from 3rd day of the menstrual cycle. A transvaginal ultrasound was performed to evaluated the endometrial thickness before and after treatment, the follicularometeric was measured on day 11 and day13. Uterine artery Doppler was then measured. Qualitative serum B-hCG level was checked 14 days after ovulation to assess clinical pregnancy rate. Design: Prospective, Double blinded randomized controlled trial. Setting: Obstetrics & Gynecology outpatient clinic, Ain Shams University Hospital. Study duration: 3 months. Results: The present study was a double-blind, randomized, controlled study that was conducted on 65 women with PCOS who underwent induction of ovulation by Clomiphene citrate in outpatient clinic of Ain Shams University hospital. Conclusion: Our systematic review and meta-analysis showed that follicular supplementation of sildenafil citrate (oral or vaginal), alone or adjuvant therapy can be used for improving the EM and clinical pregnancy rate in women undergoing assisted reproduction. However, given the methodological limitations the current evidence does not support its use in clinical practice yet. Future high-quality RCT with large sample size to evaluate the sildenafil citrate effect in women undergoing assisted reproduction are needed. Future RCTs should focus on type of processing, stage of embryo, embryo quality, dosage, time of administration, type of control group, in order to identify the groups of patients who would benefit the most from this intervention and the most appropriate dosage, time, and type of sildenafil citrate which would have the most positive effect and the less possible side effects.

Download Full-text

Factors Associated With Dropout of Participants in an App-Based Child Injury Prevention Study: Secondary Data Analysis of a Cluster Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/21636 ◽

2021 ◽

Vol 23 (1) ◽

pp. e21636

Author(s):

Jie Li ◽

Peishan Ning ◽

Peixia Cheng ◽

David C Schwebel ◽

Yang Yang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Demographic Characteristics ◽

Parenting Education ◽

Control Group ◽

Child Injury ◽

Factors Associated ◽

Randomized Controlled ◽

Study Participants

Background Mobile health (mHealth) interventions offer great potential to reach large populations and improve public health. However, high attrition rates threaten evaluation and implementation of mHealth intervention studies. Objective We explored factors associated with attrition of study participants in an mHealth randomized controlled trial (RCT) evaluating an intervention to reduce unintentional child injury risk in China. Methods The cluster RCT compared two groups of an app-based intervention for caregivers of 3-6–year-old children (Bao Hu San). The intervention group received unintentional child injury and parenting education, whereas only parenting education was implemented in the control group. The trial included 2920 study participants in Changsha, China, and lasted 6 months. Data on participant engagement (using the app) were collected electronically throughout the 6-month period. Associations between participant attrition and demographic characteristics, and between attrition and intervention engagement were tested and quantified separately for the intervention and control groups using the adjusted odds ratio (aOR) based on generalized linear mixed models. Results In total, 2920 caregivers from 20 eligible preschools participated, with 1510 in the intervention group and 1410 in the control group. The 6-month attrition rate differed significantly between the two groups (P<.001), at 28.9% (437/1510) in the intervention group and 35.7% (503/1410) in the control group. For the intervention group, the only significant predictor of attrition risk was participants who learned fewer knowledge segments (aOR 2.69, 95% CI 1.19-6.09). For the control group, significant predictors of attrition risk were lower monthly login frequency (aOR 1.48, 95% CI 1.00-2.18), learning fewer knowledge segments (aOR 1.70, 95% CI 1.02-2.81), and shorter learning durations during app engagement (aOR 2.39, 95% CI 1.11-5.15). Demographic characteristics were unrelated to attrition. Conclusions Engagement in the app intervention was associated with participant attrition. Researchers and practitioners should consider how to best engage participants in app-based interventions to reduce attrition. Trial Registration Chinese Clinical Trial Registry ChiCTR-IOR-17010438; http://www.chictr.org.cn/showproj.aspx?proj=17376 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-018-5790-1

Download Full-text

Effectiveness of an Educational Video in Maternity Wards to Prevent Self-Reported Shaking and Smothering during the First Week of Age: A Cluster Randomized Controlled Trial

Prevention Science ◽

10.1007/s11121-020-01145-z ◽

2020 ◽

Vol 21 (8) ◽

pp. 1028-1036

Author(s):

Takeo Fujiwara ◽

Aya Isumi ◽

Makiko Sampei ◽

Yusuke Miyazaki ◽

Fujiko Yamada ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Educational Video ◽

Health Checkup ◽

Infant Crying ◽

Randomized Controlled ◽

Cluster Randomized ◽

And Control

Abstract This study aimed to investigate whether watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduces self-reported shaking and smothering, at a 1-month health checkup. A cluster randomized controlled trial, stratified by area and hospital function, was employed in 45 obstetrics hospitals/clinics in Osaka Prefecture, Japan. In the intervention group, mothers watched an educational video on infant crying and the dangers of shaking and smothering an infant, within 1 week of age, during hospitalization at maternity wards, without blinding on group allocation. Control group received usual care. A total of 4722 (N = 2350 and 2372 for intervention and control group, respectively) mothers who delivered their babies (still birth and gestational age < 22 weeks were excluded) between October 1, 2014, and January 31 were recruited. Outcomes were self-reported shaking and smothering behaviors, knowledge on infant crying and shaking, and behaviors to cope with infant crying, assessed via a questionnaire at a 1-month health checkup. In all, 2718 (N = 1078 and 1640) responded to the questionnaire (response rate: 58.3%), and analytic sample size was 2655 (N = 1058 and 1597 for intervention and control group, respectively). Multilevel analysis was used to adjust for correlation within the cluster. Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%). Intention-to-treat analysis showed an 89% reduction in the reported prevalence of self-reported shaking (OR: 0.11, 95% CI: 0.02–0.53) due to watching the educational video. However, self-reported smothering behavior showed no significant reduction (OR: 0.66, 95% CI: 0.27–1.60). No side effects were reported. Watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduced self-reported shaking at 1 month of age. UMIN Clinical Trial Registry UMIN000015558.

Download Full-text

Effects of low intensity pulsed ultrasound to reduce the effusion volumes and pain with knee osteoarthritis: a randomized controlled trial

International Journal of Research in Orthopaedics ◽

10.18203/issn.2455-4510.intjresorthop20185145 ◽

2018 ◽

Vol 5 (1) ◽

pp. 77

Author(s):

P. Shanmuga Raju ◽

Chokkarapu Ramu ◽

N. S. Harshavardhan ◽

K. Rajender ◽

G. Sachin

Keyword(s):

Randomized Controlled Trial ◽

Knee Osteoarthritis ◽

Controlled Trial ◽

Control Group ◽

Ultrasound Therapy ◽

Pulsed Ultrasound ◽

Low Intensity Pulsed Ultrasound ◽

Low Intensity ◽

Randomized Controlled ◽

And Control

Background: The study aim was to determine the effect of low intensity pulsed ultrasound therapy to reduce the effusion volumes and pain in patients with Knee OA.Methods: This study design was randomized controlled trial. Total 50 patients diagnosed with Knee osteoarthritis were randomly assigned to two groups. Group I was using treatment of low intensity pulsed ultrasound therapy and group II was administered TENS with home exercise respectively. Treatments were 6 days per week and duration of 2 week. The amount of effusion volume will be measured via ultrasonograpy in knee.Results: The maximum number of cases are lying in age group >60 years which is 28% and 40% in cases and control group respectively and age distribution in both the group is statistically not significant. The mean age of patients in cases and control group is 57.08±7.40 years and 58.04±9.93 years respectively.Conclusions: Low intensity pulsed ultrasound therapy significantly reduced the effusion volumes and pain in patients with knee osteoarthritis.

Download Full-text

The effectiveness of an interactive organ donation education intervention for Dutch lower-educated students: a cluster randomized controlled trial

10.21203/rs.2.12387/v2 ◽

2019 ◽

Author(s):

Esther Steenaart ◽

Rik Crutzen ◽

Math JJM Candel ◽

Nanne K de Vries

Keyword(s):

Randomized Controlled Trial ◽

Organ Donation ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Post Test ◽

Cluster Randomized ◽

And Control ◽

Experimental Group

Abstract Background: Organ donation registration rates remain low, especially among people with lower educational levels. An interactive educational intervention was developed to prepare lower-educated students in the Netherlands for making a well-informed decision about organ donation. This article reports on the effects of this intervention on the intention to register (i.e. the primary outcome in the study at hand) and beliefs regarding organ donation. Methods: The effectiveness was investigated in a post-test only cluster randomized controlled trial, in which the intervention was offered to the experimental group and after measurement also to the control group. Randomization to the experimental and control groups took place at a class level. Teachers of schools for intermediate vocational education who taught a course on Citizenship delivered three intervention elements (i.e. video fragments and discussion, quizzes with tailored feedback and exercise filling out a registration form) to their students during two 50-minute lessons. Results: A total of 1170 students participated in the trial and filled out a questionnaire (45 experimental and 43 control classes). Compared to the control group, students in the experimental group had higher odds of having positive registration intentions (OR=1.81; 95%CI [1.10-2.96]), their perceived knowledge was higher (B=.62; 95%CI [.23-1.01]) and they had higher intentions to talk to family members (B=.68; 95%CI [.28-1.08]) and friends (B=.36; 95%CI [.07-.66]) about organ donation. There were no effects on the choice students intended to register (OR=1.08; 95%CI [.67-1.73]). Conclusions: Providing education in a classroom setting is an effective tool in increasing registration intentions. Despite uncertainties about the effects on actual registration behavior, a larger scale dissemination of this intervention is recommended. Providing clear information and opening the discussion about organ donation is an important and promising first step towards higher registration rates. Trial registration: The Dutch Trial Register, NTR6771. Registered on 24 October 2017. https://www.trialregister.nl/trial/6557

Download Full-text

Prenatal Administration of Betamethasone and Neonatal Respiratory Distress Syndrome in Multifetal Pregnancies: A Randomized Controlled Trial

Current Clinical Pharmacology ◽

10.2174/1574884714666191007154936 ◽

2020 ◽

Vol 15 (2) ◽

pp. 164-169

Author(s):

Fatemeh Abbasalizadeh ◽

Khadijeh Pouya ◽

Raana Zakeri ◽

Rana Asgari-Arbat ◽

Shamsi Abbasalizadeh ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Premature Infants ◽

Distress Syndrome ◽

Controlled Trial ◽

Intervention Group ◽

Neonatal Outcomes ◽

Control Group ◽

Randomized Controlled ◽

Neonatal Respiratory Distress ◽

And Control

Background: Neonatal Respiratory Distress Syndrome (NRDS) is one of the most frequent causes of neonatal mortality especially in premature infants. Although it has been well established that maternal antenatal corticosteroid therapy has a positive effect on NRDS reduction, yet the effectiveness of this treatment in multifetal pregnancies is dubious. Objective: We aimed to investigate the effect of betamethasone therapy on the incidence of NRDS in multifetal pregnancies through a randomized controlled trial. Method: 140 women with a multifetal pregnancy at less than 28 weeks’ gestational age were randomly allocated into intervention and control groups. Women at the intervention group received intramuscularly betamethasone (12 mg/kg/BW twice). Neonatal outcomes were evaluated between two groups of intervention and control, and two subgroups of preterm and term births. This study is registered with the Iranian Clinical Trials Registry, number IRCT20180227038879N1. Result: The incidence of NRDS was significantly lower in infants of betamethasone group than the ones in the control group (4.9% vs 18.1%, P=0.034) while it did not show a significant reduction in preterm infants compared to mature ones. Also, the intervention group presented a significant lower neonatal ventilation than the control group (47.2% vs 63.2%, P=0.041). Other neonatal outcomes, including age at birth, birth weight, Apgar score, NICU admission, and the number of mortalities were not significantly different between study groups. Conclusion: Betamethasone therapy during 28-32 weeks of gestation in multifetal pregnancies was associated with better neonatal outcomes through significant reductions in NRDS incidence and requiring ventilator treatment. However, betamethasone administration did not reduce the chance of NRDS in premature infants.

Download Full-text

Contributions of auriculotherapy in smoking cessation: a pilot study

Revista da Escola de Enfermagem da USP ◽

10.1590/s0080-6234201400005000015 ◽

2014 ◽

Vol 48 (5) ◽

pp. 883-890

Author(s):

Roberta de Paiva Silva ◽

Erika de Cássia Lopes Chaves ◽

Sandra Cristina Pillon ◽

Andréia Maria Silva ◽

Denis da Silva Moreira ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Pilot Study ◽

Controlled Trial ◽

Control Group ◽

Double Blind ◽

Future Studies ◽

Randomized Controlled ◽

And Control ◽

Experimental Group

Objective To evaluate the contribution of auriculotherapy in smoking cessation. Method Double-blind randomized controlled trial, conducted with 30 smokers allocated into two groups: Experimental Group (21 participants received 10 sessions of auriculotherapy at specific points for smoking) and Control Group (nine participants received auriculotherapy in points that have no effect on the focus of research). Results Auriculotherapy contributed in reducing the number of cigarettes smoked in 61.9% of participants (p=0.002), in reducing the difficult to abstain from smoking in places where it is forbidden by 38% (p=0.050) and in not smoking when ill 23.8% (p=0.025). Conclusion Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters, we suggest that future studies consider the use of auriculotherapy combined with other treatment methods, in order to achieve better results in cessation/abstinence.

Download Full-text