Phase III, IV clinical trials
Contracting with agencies that sponsor sexual and reproductive health trials
In-Vitro Diagnostics Research
Coordination for multi-site clinical trials
Social science research
Comparing Different Pain Management Methods for Participants Undergoing First-Trimester Surgical Abortion
This study compared the effectiveness and acceptability of different methods used to reduce pain levels in first-trimester surgical abortion with local anesthesia. Methods included 1. no additional medication, 2. lorazepam taken sublingually (under the tongue), and 3. intravenous (IV) sedation with fentanyl and midazolam. Results revealed that the third method was most effective in reducing pain scores overall.
Bleeding Patterns After EC Pill Use
In this study, bleeding patterns were observed in patients taking emergency contraception pill (ECP). Participants recorded bleeding patterns for nine weeks, and it was found that the timing of ECP administration had a significant impact on bleeding patterns.
Success Rates of Buccal vs. Oral Misoprostol in Medication Abortions
This study compared the efficacy of two different methods of taking medication abortion medication. Participants took the initial dose of mifepristone and then either took misoprostol orally (swallowed) or buccally (within cheeks) 24-36 hours later. Results showed that both methods had relatively similar success rates, but that the oral method was less effective as gestational age increased.
Comparing Types of Medication Abortions
This paper describes the different types of medication abortions and outlines the efficacy and ideal timing of each type. Results of this review indicate that mifepristone followed by misoprostol is the most common and most effective form of medication abortion available.
Comparing Oral and IV Sedation for Patients Undergoing First-Trimester Surgical Abortions
In this study, patients undergoing first-trimester surgical abortions were provided with either an oral or intravenous (IV) form of sedation in order to see which resulted in lower levels of pain. Results showed that oral sedation is almost half as effective at controlling pain levels when compared to IV sedation.
Improving Oral Contraceptive Pill Adherence Using Daily Text Message Reminders
In this study, the impact of text message reminders on oral contraceptive pill (OCP) adherence was explored. Selected participants received a daily reminder text message and pill-taking was tracked using a wireless monitor. Results did not indicate that reminder texts resulted in higher OCP medication adherence.
The Extended Gestational Age Medication Abortion Study
This study compared the efficacy, safety, and acceptability of medication abortion in patients undergoing abortions ranging from 64 to 70 days. Patients were provided with the same standard protocol for Medication Abortions ranging from 57 to 63 days (200 mg mifepristone followed by 800 μg misoprostol 24-48 hours later). Results showed similar rates of efficacy, suggesting that Medication Abortions can be administered effectively for up to 70 days.
Are symptoms alone adequate to determine Medication Abortion Success?
The purpose of this study was to assess patients’ ability to predict success of medication after undergoing a medication abortion. While self-assessment was helpful, results indicated that a pregnancy test should ideally still be required in order to ensure predictions were accurate.
Assessing Patient Pain Control Preferences During First-Trimester Surgical Abortions
In this study, participants were asked what method of pain control they preferred when undergoing a first-trimester surgical abortion. Methods discussed included intravenous (IV) and local anesthesia. Results indicated that most participants would recommend IV anesthesia due to lower pain scores, but that decision-making should be done on a case-by-case basis.
Comparing Medication and Synthetic Dilator Cervical Preparation Methods Before Surgical Abortion
In this study, two methods of cervical preparation were compared in patients undergoing early surgical abortion. Methods compared were misoprostol, a medication placed within the mouth to soften the cervix, and dilapan-STM, a rod that gently expands the cervix. Results showed that both methods were similarly favorable and effective for patients, despite more painful side effects with misoprostol.
Comparing the effectiveness of blood test to an ultrasound for medication abortion follow-up.
In this study, serum human chorionic gonadotropin (hCG) testing (a blood test) and ultrasound testing, were compared to see they were equally effective at confirming complete abortion after mifepristone and misoprostol. Results showed that both methods of follow-up were comparable and patients did not need to return to clinic for an ultrasound (previously required).
Comparing Pain Management Methods in First-Trimester Surgical Abortion Patients
This study compared oral nonsteroidal anti-inflammatory medications (NSAIDs) to ketorolac injections in patients receiving first-trimester abortions. Results show an insignificant difference in pain control between both medications, suggesting that ketorolac may not be necessary as a pain reduction measure unless the patient is unable to tolerate NSAIDs.
Comparing Cervical Preparation Methods Before Surgical Abortion
This study investigated the impact of different preparations methods on the time taken to complete a surgical abortion. The methods being compared were 1. use of overnight dilators to dilate the cervix, 2. dilators and mifepristone, and 3. dilators and misoprostol. Results showed that the second method was the most preferred method, despite no difference in the time it took to complete the surgical abortion due to less negative side effects overall.
hCG Level Trends After Early Medication Abortion
In this study, the levels of human chorionic gonadotropin (hCG) in patients undergoing early medication abortion were measured in order to verify lower hCG levels after the procedure. Results showed a decline in serum hCG within the first few days after Medication Abortion, which be helpful for confirming the completion of the regimen.
Immediate vs. Delayed Insertion of IUD in Cesarean Patients in Uganda
This study compared the timing of Copper T380A intrauterine devices (IUD) in patients undergoing cesarian section in Uganda. IUDs were either implanted the day of the procedure or six weeks afterwards. Results showed that immediate IUD insertion resulted in higher rates of use, satisfaction, and lower complications compared to delayed IUD insertion.
Comparing Cerival Dilation methods among Patients Receiving a First-Trimester Surgical Abortion
This paper reviews the evidence that outlines the risks, benefits and alternatives to cervical priming in the first trimester before procedural abortion.
Using Naprosyn for Pain Control During IUD Insertion Procedure
The purpose of this study was to see whether providing patients with naproxen sodium (Aleve) was helpful for pain relief during intrauterine device (IUD) insertion. Results showed that naproxen sodium did not decrease pain levels during the procedure but was helpful in reducing pain levels afterwards, suggesting that it may be useful to take before IUD insertion.
Effects of DMPA Injection Timing on Medication Abortion Completion and Repeat Pregnancies
Patients who wanted depot medroxyprogesterone acetate (DMPA) for contraception, were provided it either on the day of taking mifepristone for medication abortion or at a return visit, to see if immediate initiation of DMPA increased usage of effective birth control after a medication abortion and if giving this higher-dose progestin contraceptive together with an anti-progesterone, increased abortion failure rates. Results showed that patients receiving DMPA at the time of mifepristone had a higher risk of ongoing pregnancy (medication abortion failure) and were not more likely to be using highly effective contraception at 6 months.
Effects of Nexplanon Insertion Timing on Medication Abortion Completion and Repeat Pregnancies
Patients who desired etonogestrel implants (Nexplanon) for contraception, were provided with their implant either on the day they took mifepristone for medication abortion, or when they returned for follow up, to see if timing of Nexplanon insertion decreased likelihood of repeat pregnancy within 6 months, and if it was associated with medication abortion failure (ongoing pregnancy after abortion pills). Results showed no effect on the medication abortion and decreased risk of another pregnancy within 6 months.
Rate of Chlamydia Transmission Among DMPA and OCP Users
In this study, reproductive-aged individuals provided data for the Safe Sex Behavior Questionnaire to assess whether birth control type was associated with Chlamydia infection. Patients were using depot medroxyprogesterone acetate (DMPA) or the oral contraceptive pill (OCP). Results showed that DMPA was not associated with higher chlamydia risk, although low rates of chlamydia in the population limited findings.
hCG Trends within the first few days After Medication Abortion
In this study, human chorionic gonadotropin (hCG) levels were measured within the first few days after medication abortion. Results showed highly variable levels on Day3, but a a predictable decline in hCG levels as soon as 5 days after Medication Abortion. This data is now commonly used in the clinical management of medication abortion follow-up.
Impact of Advanced Notice of Birth Control Options on Surgical Abortion Patient Outcomes
In this study, patients receiving a surgical abortion were either only given details over the phone about their appointment in preparation for the procedure or were also provided with information about birth control methods and types during the call. Results showed that patients who received information about birth control options before their appointment were more knowledgeable about birth control options. This suggests that giving surgical abortion patients information about birth control beforehand may be helpful in improving knowledge and attitudes toward birth control overall.
Use of Algorithm-Based Sedation on Patient Satisfaction During Surgical Abortion Procedure
In this study, the impact of 'algorithm-based' sedation dosing was compared to 'standard-of-care' (clinical judgement) sedation dosing for patients undergoing surgical abortions. Results showed that algorithm-based sedation did not produce differences in pain scores in patients overall.
Comparing Outcomes of IV Sedation in First Trimester Surgical Abortions Based on Patient BMI
This study was conducted to see if patients with BMI over 30 had more adverse side effects to intravenous (IV) sedation during surgical abortion compared to patients with a body mass index (BMI) of 25 or less. Results showed that side effects were rare, and there were no increased adverse events observed amongst patients with higher BMI. This led to changes in clinical protocols that enabled provision of sedation to obese abortion patients in Planned Parenthood settings.
Exploring Factors that Influence Initiation of LARC in Surgical Abortion Patients
This study described the rate of initiation of long-acting reversible contraception (LARC) methods at the time of surgical abortion among patients in a state with good insurance coverage. Results showed that 25% of participants opted for intrauterine devices (IUD) or implantable contraception, suggesting that when same-day access to LARC is available to patients undergoing a surgical abortion a large percentage choose it.
Impact of Community-Based Postpartum Counseling in Contraception use in Patients in Rural Nepal
This study explored the impact of interdisciplinary postnatal counseling in patients in rural Nepal. Results showed that contraception use increased from 29% to 46% post-counseling, suggesting that this method may be effective for improving contraceptive outcomes in patients who have recently given birth.
LARC Use in Patients with Opioid Use Disorder Receiving a Surgical Abortion
This study described the rate of long-acting reversible contraception (LARC) uptake among abortion patients using medications for opioid use disorder (MOUD) at the time of surgical abortion. Results showed that patients on MOUD were more likely to initiate LARC compared to those not on MOUD, likely due in part to the access provided via public insurance coverage for the abortion procedure and the LARC method.
Comparison of Two Differently Sized Copper IUDs
The purpose of this study was to compare first-year continuation and IUD removal rates in patients with no history of pregnancy across 16 US-based health centers. Data regarding reasons for removal and expulsion of IUDs were collected for TCu380A and NT380-Mini models. Results showed that the NT380-Mini IUD was associated with lower discontinuation and expulsion rates, with less complications overall.
Timing of Medication Abortions for Pregnancy of Unknown Location
The purpose of this study was to evaluate the safety of offering medication abortion treatment to patients with an unwanted pregnancy that could not be detected on an ultrasound. Participants were either provided with medication abortion on the same day as their appointment (when they were diagnosed with a non-visible pregnancy) or waited until a repeat ultrasound was performed to confirm an intrauterine pregnancy prior to starting the medication abortion. Results showed that it was safe to take the medications before the pregnancy can be seen on ultrasound, and immediate-start patients ended the pregnancy more quickly, but immediate-start had a higher rate of ongoing pregnancy (and suction procedure) than medication abortion after an intrauterine pregnancy could be seen on ultrasound.
Using At-Home Pregnancy Tests After Medication Abortion for Pregnancy of Unknown Location
Patients with pregnancies of unknown location (PUL) confirmed by an ultrasound underwent a medication abortion and were asked to confirm completion of the procedure using a home urine pregnancy test after 14 days. Patients also confirmed the pregnancy test with an in-clinic serum human chorionic gonadotropin (hCG) test. Results indicated that all urine pregnancy tests were negative, among the patients who took the test 14 days or later.
Comparing Complications in Same-Day vs. Overnght Cervical Preparation Before Surgical Abortion Procedure
In this study, cervical preparation methods and timing were compared for patients undergoing surgical abortion ranging from 14 to 16 weeks gestation. Both overnight and same-day preparation methods resulted in low rates of complications, indicating that same-day cervical preparation for early second trimester surgical abortions is safe.
Barriers to Abortion Decision-Making in Patients Seeking Abortions in Late Second Trimester Pregnancies
This study identified barriers associated with decision-making in patients seeking termination of later second-trimester pregnancies. Reasons identified included difficulty deciding to terminate, financial barriers to care, and patient realizing recently they were pregnant. Though financial barriers could be addressed, results indicate that many risk factors identified are nonmodifiable.
Effects of Language Use on Abortion Stigma and Perception
In this paper, the implications of terms used to describe abortion are discussed. Writers argue that terms such as "elective abortion" misrepresent the complexity and nuance surrounding patients' decision to undergo abortion procedures and should be eliminated from medical conversation in order to ensure that clinicians are able to view the procedure objectively.
Role of Stigma in Burnout Rate in Hospital-Based vs. Clinic-Based Abortion Care Providers
The rate of burnout based on worksite conditions was assessed in abortion providers and support staff working in clinics and hospitals. Results show that hospital-based abortion workers experience a lower risk of burnout compared to workers in clinics, likely due to lower rates of stigma at the worksite.
Impact of Judicial Bypass on Timing for Minors Seeking Abortion Without Parental Consent in Massachusetts
This study explored the delay in abortion access resulting from the judicial bypass system in Massachusetts. Results indicate that the time spent waiting for judicial bypass was over double that of minors who had obtained parental consent, which may have implications on clinical options available to patients.
Contraceptive Decision-Making in MA Adolescents Post-Abortion
This study assessed birth control use post-abortion based on insurance type and regulations. Patients who did not use insurance to pay for their abortions were less likely to opt for long-acting reversible contraception (LARC) such as intrauterine devices (IUD) and implants (Nexplanon), suggesting that insurance coverage is correlated with higher chances of birth control use.
Gender Diversity Among Patients Seeking Abortion Services
The purpose of the study was to describe gender identities of patients who had received surgical abortions. Using multi-site survey data on abortion care, researchers found a wide variety of self-reported gender identities in patients undergoing abortion procedures. Findings further emphasize the importance of providing gender-inclusive abortion care.
The Financial Burden of Judicial Bypass on Minors Seeking Abortion in Massachusetts
PPLM data from 2010-2016 was analyzed to assess the financial burden on minors associated with obtaining judicial bypass in Massachusetts for abortion access. Costs associated with this process averaged 20.2% of monthly income on average, with the highest financial burden falling on minors of lower socioeconomic status.
Impact of COVID-19 on Abortion Care in Massachusetts
This study investigated the impact of the COVID-19 pandemic on abortion care in Massachusetts. Results showed that there was a 20% drop in abortions among adults and a 27% reduction among minors. Further research is needed to assess potential additional factors responsible for this trend.
The Impact of Abortion Access Restriction Levels on Innovative Clinical Practices
This study assessed whether abortion restrictions resulted in a different rate of innovative practices. Results suggest that states with stricter abortion access laws were less likely to adopt innovative practices, and vice versa.
Rates of Abortion after Overturning of Roe v. Wade in Massachusetts
In this paper, the rates of abortion access before and after the Dobbs Supreme Court decision were compared at Planned Parenthood League of Massachusetts, a provider of more than 50% of abortions in the state. Results showed that there was a 37.5% increase in abortions for patients traveling out-of-state and a 1.2% increase in abortions for Massachusetts residents
Barriers to Mifepristone Use for EPL Patients in Massachusetts
A cohort of obstetrician-gynecologists (OB/GYNs) was used to assess the reasoning behind low rates of mifepristone use for patients experiencing early pregnancy loss (EPL). Results showed that the biggest barrier to use was related to the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) imposed by the Food and Drug Administration (FDA), as well as the medications' association with abortion.
Using Mifepristone to Manage Pregnancy Loss
A survey was completed by a cohort of obestrician-gynecologists (OB/GYN) in Massachusetts to assess the amount of times providers provided medications such as mifepristone and misoprostol to patients experiencing pregnancy loss. Despite its effectiveness, results revealed that around half of OB/GYNs did not use mifepristone due to lack of experience with the drug and Food and Drug Administration (FDA) regulations.
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