What Are the Pregnancy Rates When Combined Oral Contraceptive Pills Are Missed?
BACKGROUND AND PURPOSE:
Creinin et al. (Obstretrics & Gynecology, 2023) assessed the relationship of adherence and pregnancy in participants using a combined oral contraceptive
METHODS:
Secondary analysis of two parallel, multicenter, phase 3 trials
Population
16 to 35 years old
Receiving a combined oral contraceptive (estetrol 15 mg and drospirenone 3 mg)
Using a 24 hormone and 4 placebo pills regimen for up to 13 cycles
Exposures
Participant reported
Pill intake | Sexual intercourse | Other contraceptive use
Study design
Efficacy analysis was restricted to at-risk cycles (one or more reported acts of intercourse and no other contraceptive use)
Cycles with other contraceptive use were excluded, unless pregnancy occurred in that cycle
Primary outcome
Association between number of pills not taken per cycle and pregnancy
Secondary outcome
When pregnancies occurred during contraceptive use
RESULTS:
2837 participants
At-risk cycles: 26,455
On-treatment pregnancies: 31
Occurrence of pregnancy based on missing pills (P<0.001)
No missed pills: 0.09%
1 missed pill: 0.25%
2 missed pills: 0.83%
>2 missed pills: 1.6%
No pregnancies occurred when one or more pills were missed and missed-pill instructions were followed
All pregnancies related to not taking pills occurred in the first three cycles
CONCLUSION:
In a 28-day cycle, there is a higher rate of pregnancy when oral contraceptive pills are missed
The pregnancy rate exceeds 1% only when more than 2 pills are missed
Following missed-pill instructions seems to reduce the incidence of pregnancy
The authors state
We found that the pregnancy risk per cycle was very low (0.09%) in participants who reported using all active hormone pills in a particular cycle, regardless of any new medications started or health issues
Are Abnormal Copy Number Variants Associated with Stillbirth and Fetal Growth Abnormalities?
BACKGROUND AND PURPOSE:
Fetal growth abnormalities, like small and large for gestational age (SGA, LGA), are associated with an increased risk of stillbirth
Many cases of SGA and LGA are not associated with any known clinical risk factors, and may be related to an unknown underlying genetic etiology
Dalton et al. (AJOG, 2023) assessed the relationship between abnormal copy number variants and fetal growth abnormalities in stillbirths using chromosomal microarray
METHODS:
Cohort study
Population
Stillbirths in the Stillbirth Collaborative Research Network
Exposure
Abnormal copy number variants including aneuploidies, pathogenic copy number variants, and variants of unknown clinical significance
Study design
Copy number variants determined using microarray (fetus or placenta)
Primary outcomes
SGA stillbirths: birthweight <10th percentile for gestational age
LGA stillbirths: >90th percentile for gestational age
RESULTS:
393 stillbirths
Abnormal copy number variants: 16%
The SGA stillbirth outcome was more common among those with abnormal copy number variants (P=0.038)
Abnormal: 29.5% | Normal: 16.5%
Odds ratio (OR) 2.22 (95% CI, 1.12 to 4.18)
LGA age stillbirths were no more likely to have an abnormal microarray (P=0.275)
Abnormal: 6.2% | Normal: 3.3%
OR 2.35 (95% CI, 0.70 to 7.90)
CONCLUSION:
Abnormal copy number variants are more common in SGA stillbirths
The authors state
Our findings support the recent recommendations for chromosomal microarray in the evaluation of a stillbirth as opposed to karyotyping, especially in the setting of growth restriction, as roughly half of the genetic abnormalities associated with SGA stillbirths would not have been discovered with conventional karyotyping
Meta-Analysis: Elective Induction at 39 Weeks and Rates of Maternal Labor-Related Complications
BACKGROUND AND PURPOSE:
Hong et al. (JAMA Network Open, 2023) examined maternal labor-related complications and neonatal outcomes following elective induction of labor at 39 weeks vs expectant management
Induction of labor at 39 weeks of gestation reduced the likelihood of
Third- or fourth-degree perineal injury: OR 0.63 (95% CI, 0.49 to 0.81)
Operative vaginal birth: OR 0.87 (95% CI, 0.79 to 0.97)
Macrosomia: OR 0.66 (95% CI, 0.48 to 0.91)
Low 5-minute Apgar score: OR 0.62 (95% CI, 0.40 to 0.96)
Results were similar when confined to multiparous women only, with the addition of
A reduction in the likelihood of emergency cesarean section
OR 0.61 (95% CI, 0.38 to 0.98)
No difference in operative vaginal birth
OR 1.01 (95% CI, 0.84 to 1.21)
Among nulliparous women only, induction of labor was associated with an increased likelihood of shoulder dystocia
OR 1.22 (95% Ci, 1.02 to 1.46)
CONCLUSION:
Induction of labor at 39 weeks reduced the incidence of perineal injuries, macrosomia and low 5-min Apgar scores
Among multiparous women, it also reduced the likelihood of an emergency cesarean delivery
Among nulliparous women, induction at 39 weeks was associated with shoulder dystocia
The authors state
This review of 1 625 899 women from 14 studies found that elective induction of labor at 39 weeks of gestation compared with expectant management was associated with improved labor-related outcomes, including a 37% reduction in perineal injury risk
Meta-Analysis: Comparing Different Antiosteoporosis Medications and Fracture Risk Reduction
BACKGROUND AND PURPOSE:
Händel et al. (BMJ, 2023) assessed the comparative effectiveness of osteoporosis treatments on reducing the risk of fractures in postmenopausal women
METHODS:
Systematic review, network meta-analysis, and meta-regression analysis
Inclusion criteria
Randomized clinical trials
Studies that examined the effect of bisphosphonates, denosumab, selective estrogen receptor modulators, parathyroid hormone receptor agonists, and romosozumab compared with placebo or active comparator
Studies that included non-Asian postmenopausal women with no restriction on age
Study design
Bias and heterogeneity were assessed
Primary outcome
Clinical fractures
Secondary outcomes
Vertebral, non-vertebral, hip, and major osteoporotic fractures
Harm outcomes: All-cause mortality | Number of patients with any adverse events | Number of patients with serious cardiovascular adverse event
RESULTS:
69 trials | >80,000 patients
Compared to placebo, the following provided protection against clinical fractures
Compared with parathyroid hormone receptor agonists, bisphosphonates were less effective in reducing clinical fractures
Odds ratio (OR) 1.49 (95% CI, 1.12 to 2.00)
Compared with parathyroid hormone receptor agonists and romosozumab, denosumab was less effective in reducing clinical fractures
Parathyroid hormone receptor agonist vs denosumab: OR 1.85 (95% CI, 1.18 to 2.92)
Romosozumab vs denosumab: OR 1.56 (95% CI, 1.02 to 2.39)
Compared to placebo, all treatments provided protection against vertebral fractures
The effect of all treatments was unaffected by baseline risk indicators except for antiresorptive treatments showed a greater reduction of clinical fractures compared with placebo with increasing mean age
There were no harm outcomes observed
Certainty of effect estimates was moderate to low
CONCLUSION:
Many antiosteoporosis medications provided protection against clinical and vertebral fractures in postmenopausal women
Bone anabolic treatments were more effective than bisphosphonates
The authors state
Because bone anabolic treatments were more effective than bisphosphonates, irrespective of the baseline risk, no evidence from clinical trials exists supporting the view that bone anabolic treatment should be limited to patients at very high risk of fractures because of efficacy
RCT Results: IV vs Oral Iron for Postpartum Anemia?
BACKGROUND AND PURPOSE:
Saad et al. (Obstetrics & Gynecology, 2023) evaluated the feasibility of administering IV iron postpartum prior to discharge for the management of anemia
Treatment for Cesarean Scar Ectopic Pregnancy: D&E or Hysteroscopic Resection?
BACKGROUND AND PURPOSE:
There is no consensus on best treatment practices for managing cesarean scar ectopic pregnancy (CSP)
Di Spiezio Sardo et al. (AJOG, 2023) compared the success rate of hysteroscopic resection vs ultrasound-guided dilation and evacuation (D&E) for treatment of CSP
Is Interrupting Breast Cancer Therapy During Pregnancy a Safe Approach?
BACKGROUND AND PURPOSE:
Partridge et al. (NEJM, 2023) assessed the risk of breast cancer recurrence associated with a temporary interruption of endocrine therapy to attempt pregnancy in premenopausal women with endocrine-responsive early breast cancer
Received adjuvant endocrine therapy for 18 to 30 months
516 women
Median age: 37 years
Median time from breast cancer diagnosis to enrollment: 29 months
Stage I or II disease: 93.4%
Exposure
Temporary interruption of adjuvant endocrine therapy to attempt pregnancy
A control cohort consisted of women who would have met the criteria for enrollment in the trial
Study design
Primary analysis was planned to occur after 1600 patient-years of follow-up
The prespecified safety threshold was the occurrence of 46 breast cancer events during this period
Primary outcome
Number of breast cancer events during follow-up
Events were defined as local, regional, or distant recurrence of invasive breast cancer or new contralateral invasive breast cancer
RESULTS:
516 women
Median age: 37 years
Median time from breast cancer diagnosis to enrollment: 29 months
Stage I or II disease: 93.4%
Patient years of follow-up: 1638
Median follow-up: 41 months
Pregnancy rate: 74.0% | Live birth rate: 63.8%
Breast cancer events: 44
This number did not exceed the prespecified safety threshold
3-year incidence of breast cancer events
Treatment interruption: 8.9% (95% CI, 6.3 to 11.6)
Control: 9.2% (95% CI, 7.6 to 10.8)
CONCLUSION:
Temporary cessation of endocrine therapy to attempt pregnancy did not increase the incidence of breast cancer recurrence in the short-term
Long-term follow-up is necessary to ensure safety of treatment interruption
The authors state
In well-matched comparisons to an external control cohort, the POSITIVE trial showed no clear worsening of breast cancer outcomes in the short term after temporary interruption of endocrine therapy to allow for pregnancy in select women with a history of hormone receptor–positive breast cancer
RCT Results: Does Immediate GDM Treatment Prior to 20 Weeks Improve Neonatal Outcomes?
BACKGROUND AND PURPOSE:
Simmons et al. (NEJM, 2023) assessed pregnancy outcomes after treatment for GDM had been initiated before 20 weeks gestation, as compared with deferred or no treatment
METHODS:
Randomized controlled trial
Multicenter | 17 Hospitals
Participants
≥18 years
4w0d to 19w6d
≥1 risk factor for hyperglycemia
Intervention
Immediate treatment for GDM
Deferred or no treatment, depending on the results of a repeat oral glucose-tolerance test (OGTT) at 24 to 28 weeks gestation
Primary outcomes
Composite of adverse neonatal outcomes
Birth at <37 weeks’ gestation | Birth trauma | Birth weight of ≥4500 g | Respiratory distress | Phototherapy | Stillbirth or neonatal death | Shoulder dystocia
Adjusted mean difference −0.04 g (95% CI, −0.09 to 0.02)
There were no differences in serious treatment- or screening-related adverse events between the groups
CONCLUSION:
Starting GDM treatment immediately, prior to 20 weeks, led to a small reduction in adverse neonatal outcomes
No other benefits to immediate treatment with regard to pregnancy-related hypertension or neonatal body mass were notes
The authors state
In this trial involving pregnant women who had a risk factor for hyperglycemia, immediate treatment of gestational diabetes before 20 weeks’ gestation led to a modestly lower incidence of a composite of severe adverse neonatal outcomes than no immediate treatment
What are the Red-Flag Signs of Early-Onset Colorectal Cancer?
BACKGROUND AND PURPOSE:
Fritz et al. (Journal of the National Cancer Institute, 2023) identified red-flag signs and symptoms associated with early-onset colorectal cancer (CRC)
METHODS:
Matched case-control study
US population | Commerical Insurance
Population
18 to 64 years
Exposures
Early-onset CRC
Matched controls
Study design
Diagnostic intervals were assessed according to the presence of signs and symptoms before and within 3 months of diagnosis
Primary outcomes
Red-flag signs and symptoms between 3 months to 2 years before the index date
There were 17 pre-specified signs and symptoms
RESULTS:
Early-onset CRC patients: 5075
Four red-flag signs and symptoms were associated with an increased risk of early-onset CRC
Abdominal pain
Cases: 11.6% | Controls: 7.7%
Odds ratio (OR) 1.34 (95% CI, 1.19 to 1.49)
Rectal bleeding
Cases: 7.2% | Controls: 1.3%
OR 5.13 (95% CI, 4.36 to 6.04)
Diarrhea
Cases: 2.8% | Controls: 1.4%
OR 1.43 (95% CI, 1.14 to 1.78)
Iron deficiency anemia
Cases: 2.3% | Controls: 0.9%
OR 2.07 (95% CI, 1.61 to 2.66)
Having 1, 2, or ≥ 3 of these signs/symptoms was associated with increasing risk (Ptrend<0.001)
1 sign/symptom: OR 1.94 (95% CI, 1.76 to 2.14)
2 signs/symptoms: OR 3.59 (95% CI, 2.89 to 4.44)
≥ 3 signs/symptoms: OR 6.52 (95% CI, 3.78 to 11.23)
There were stronger associations for
Younger ages: Pinteraction<0.001
Rectal cancer: Pheterogenity=0.012
The number of different signs and symptoms was predictive of early-onset CRC beginning 18 months before diagnosis
First sign and/or symptom occurred between 3 months and 2 years before diagnosis: 19.3%
Median diagnostic interval: 8.7 months
First sign and/or symptom occurred with 3 months of diagnosis: 49.3%
Median diagnostic interval: 0.53 months
CONCLUSION:
Red-flag signs and symptoms of early-onset CRC are abdominal pain, rectal bleeding, diarrhea and iron deficiency anemia
The authors state
Early recognition of red-flag signs and symptoms (abdominal pain, rectal bleeding, diarrhea, and iron-deficiency anemia) may improve early detection and timely diagnosis of early-onset CRC
RCT Results: Levonorgestrel IUD or Hysteroscopic Resection for Niche-Related Bleeding?
BACKGROUND AND PURPOSE:
Niche-related postmenstrual spotting and chronic pelvic pain can occur after cesarean delivery
Both the 52-mg levonorgestrel IUD (LNG IUD) and hysteroscopic niche resection have been shown to improve symptoms
Zhang et al. (AJOG, 2023) compare the effectiveness of the 52-mg LNG IUD with hysteroscopic niche resection in reducing niche-related postmenstrual spotting
METHODS:
Randomized, open-label, controlled trial
Participants
Women with symptoms of postmenstrual spotting after cesarean delivery
Niche depth of ≥2 mm and residual myometrium of ≥2.2 mm on MRI
Not planning to conceive within the next year
Intervention
52-mg LNG IUD
Hysteroscopic niche resection
Study design
Efficacy and safety were assessed using intention-to-treat analysis
Primary outcome
Reduction in postmenstrual spotting at 6 months after randomization
Defined as percentage of women with a reduction of at least 50% in spotting days relative to baseline
There was a stronger reduction observed in the IUD group (P=0.001)
There was a significant interaction between time and treatment (P=0.007)
≥9 months: A more significant reduction in spotting was observed in the IUD group
9 months
IUD: 89.2% | Niche resection: 72.1%
RR 1.24 (95% CI, 1.08 to 1.42)
12 months
IUD: 80.2% | Niche resection: 70.2%
RR 1.29 (95% CI, 1.12 to 1.48)
IUD group had significantly
Fewer postmenstrual spotting days at ≥6 months (P<0.001)
Fewer total bleeding days at ≥6 months (P<0.001)
Less pelvic pain at ≥3 months (P<0.01)
No intervention-related complications were reported in any group
Side-effects
Hormone-related side effects: 10.8%
Spontaneous partial expulsion in IUD group: 2.0%
There were 3 unintended pregnancies in the niche resection group
CONCLUSION:
For women with niche-related postmenstrual spotting, there was no difference in spotting reduction at 6 months with levonorgestrel IUD vs hysteroscopic niche resection but by 9 months the IUD was better at reducing spotting
Pelvic pain was also improved in the IUD group as early as 3 months from intervention
The authors state
On the basis of these results, we recommend LNG-IUS as the first-line therapy for women with niche-related gynecologic symptoms and without an active desire to become pregnant
Is Increasing BMI Associated with Increased Risk of Severe Respiratory Disease Outcomes?
BACKGROUND AND PURPOSE:
Higher BMI has been associated with worse COVID-19 outcomes, but BMI’s association with other respiratory diseases is not well understood
Bohrmann et al. (JAMA, 2023) assessed the associations between BMI and risk of hospitalization or death due to COVID-19, lower respiratory tract infections (LRTIs), and upper respiratory tract infections (URTIs)
METHODS:
Population-based cohort study
Population
Individuals in the UK Biobank without chronic respiratory disease
Exposure
BMI
Study design
Cox proportional hazards models were used to determine hazard ratios (HR)
Reference group was individuals with BMI 25 to 29.9
Adjustments: Age | Sex | Region | Race | Townsend deprivation score | Education | Smoking | Alcohol intake
Primary outcome
Hospitalization or death due to COVID-19 | LRTIs (influenza, pneumonia) | URTIs (laryngitis, tonsillitis)
RESULTS:
Median age: 58 (IQR, 50 to 63) years | 54% female | 94% White
Mean BMI: 27.4 (SD, 4.7)
Mean follow-up: 11.8 years
Risk of all respiratory diseases was higher for BMI in the range of 35 to 60, compared to the reference group
COVID-19: aHR 2.38 (95% CI, 2.07 to 2.74)
LRTIs: aHR 1.91 (95% CI, 1.83 to 2.00)
URTIs: aHR 1.40 (95% CI, 1.20 to 1.64)
In the continuous analyses, there were positive log-linear associations of BMI with risk of severe COVID-19 and URTIs throughout the BMI categories
COVID-19: HR per 10-unit higher BMI 2.26 (95% CI, 2.05 to 2.49)
URTIs: HR per 10-unit higher BMI 1.37 (95% CI, 1.24 to 1.51)
There was a positive association of BMI with risk of LRTIs with BMI greater than 25
HR per 10-unit higher BMI 1.74 (95% CI, 1.68 to 1.80)
CONCLUSION:
Risk of hospitalization or death increased with increasing BMI for COVID-19 and URTIs
Risk of LRTIs increased with increasing BMI >25
The authors state
The findings suggest that the proposed mechanisms (including obesity-related chronic disease or compromised respiratory function) between BMI and COVID-19 might be shared by other LRTIs
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