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CompletedNCT04615624Updated Apr 18, 2024Results posted

Furosemide vs. Placebo for Severe Antepartum Hypertension

A Phase 3 interventional study of Furosemide and Placebo in Pre-Eclampsia, Hypertension in Pregnancy and Pregnancy Complications, sponsored by Melanie Maykin, MD. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by Melanie Maykin, MD · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Primary objective: To determine whether the addition of intravenous furosemide with usual antihypertensives is associated with a reduction in mean systolic blood pressure from baseline compared to treatment with placebo plus usual antihypertensives (intravenous labetalol, intravenous hydralazine, or oral immediate release nifedipine) for the management of severe antepartum hypertension.

Secondary objectives:

To determine whether the addition of intravenous furosemide with usual antihypertensives is associated with a reduction in mean diastolic blood pressure compared to treatment with placebo plus usual antihypertensives listed above.

Read the detailed description

Blood pressure is a measure of blood flow and resistance in blood vessels. In normal pregnancy, total blood volume increases while systemic vascular resistance decreases, thereby leading to an overall reduction in blood pressure with return to baseline at term. Hypertensive disorders in pregnancy, including preeclampsia, are a polymorphic syndrome characterized by elevated blood pressures which can affect multiple organ systems. Although the exact mechanism of preeclampsia has yet to be determined, previous studies have shown that there may be two distinct phenotypes - one characterized by vasoconstriction and diminished micro-circulation and the other involving a hyperdynamic high cardiac output state.

Given its potential for both significant maternal and fetal morbidity, hypertensive disorders in pregnancy comprise a substantial proportion of antepartum admissions. Management of acute severe hypertension (systolic blood pressure greater than or equal to 160 or diastolic blood pressure greater than or equal to 110) is important to reduce the risk of stroke, hypertensive encephalopathy, placental abruption, and heart failure or myocardial infarction. In the antepartum and intrapartum period, the use of antihypertensives including labetalol, nifedipine, and hydralazine have been well-described. Despite these options for blood pressure control, preeclampsia can be a progressive disorder that may not respond to the aforementioned agents.

In preeclampsia manifested by high blood volume due to salt and water retention rather than vasoconstriction, standard antihypertensives may be less effective. Furosemide is a commonly used diuretic that can lower blood pressure by inhibiting the absorption of sodium, chloride, and water, thereby decreasing the volume of blood that the heart pumps. The onset of action of action of IV furosemide is 5 minutes, with peak effect at 30 minutes, and duration of action of 2 hours.

Previous studies have demonstrated the safety and efficacy of furosemide to treat preeclampsia in the antepartum and postpartum period as well as its utility in treating heart failure in pregnant women. To our knowledge, no randomized studies exist that investigate the use of furosemide in treating hypertension in the antepartum period. We aim to determine the utility of the addition of furosemide to usual antihypertensives in this clinical setting.

This will be a prospective double-blinded randomized placebo control trial of women with a diagnosis of preeclampsia with severe features at ≥20 weeks of gestation with persistent antepartum hypertension (sustained systolic blood pressure ≥160 or diastolic blood pressure ≥110 mmHg) and a wide pulse pressure (>60 mmHg) who meet all inclusion criteria and have no exclusion criteria. It is routine that laboratory studies are performed on admission for all women with hypertensive disorders. If electrolyte disturbances exist, therapy will not be initiated unless the electrolyte is normalized or repleted.

After informed consent and upon meeting inclusion criteria with severe range hypertension with wide pulse pressure, the study personnel will inform pharmacy personnel who will then randomly assigned the patient to groups by opening the next previously prepared sequential and numbered opaque study envelope. Participants will be randomized to furosemide plus an antihypertensive versus placebo containing normal saline and an antihypertensive. The pharmacy staff will send the assigned treatment, which will be administered by the bedside nurse. The vials containing the treatment will be indistinguishable as both furosemide and normal saline placebo are clear, colorless solutions. Thus, the provider, nurse, and patient will be blinded to the treatment. The choice of antihypertensive will be determined by the primary obstetric provider. At our institution, this will be one or more of the recommended medications for urgent blood pressure control as outlined by the American College of Obstetricians and Gynecologists Practice Bulletin on gestational hypertension and preeclampsia. These include IV labetalol, IV hydralazine, or immediate-release oral nifedipine. As meta-analyses have not shown that one of the aforementioned antihypertensives is superior than another, and all are reasonable options, the choice of antihypertensive will be left up to the obstetric provider. This will also improve the generalizability of the study as it does not interfere with what is typically done in clinical practice.

As a procedure of the study, patients will have their blood pressure recorded at least every 15 minutes up to one hour after administration of the study drug. Thereafter, as part of routine care, patients in both groups will receive similar antepartum surveillance, including blood pressure and pulse assessment every four hours or more frequently if vital signs are abnormal, daily weight measurement, and daily urinary output measurements.

Study Procedures

  1. Antepartum patient diagnosed with a hypertensive disorder in pregnancy.
  2. Patient approached for study participation and informed consent obtained if interested.
  3. Patient develops severe range BP (systolic blood pressure > or = 160 and/or diastolic blood pressure> or =10) with increased pulse pressure (>60mmHg). This will be considered baseline BP.
  4. When ordering provider's choice of antihypertensive, pharmacy notified that patient is study participant and randomizes patient by choosing from sequential opaque envelope.

  5. a. Patient randomized to treatment arm and receives 40mg /4 milliliters IV furosemide in addition to usual antihypertensive.

    b. Patient randomized to placebo and receives 4 milliliters normal saline in addition to usual antihypertensive.

  6. Blood pressure check every 15 minutes after administration of furosemide/placebo for four recordings (15, 30, 45, 60 minutes)
02

Conditions studied

  • Pre-Eclampsia
  • Hypertension in Pregnancy
  • Pregnancy Complications
  • Hypertension, Pregnancy-Induced

Keywords

  • Severe range blood pressure
  • Pre-eclampsia
  • Gestational hypertension
  • Wide pulse pressure
  • High-risk pregnancy
  • Pregnancy complications
03

In context

Eclampsia

328 studies on the registry are indexed under Eclampsia; 48 are open to participants now.

This study's enrollment of 65 is below the median of 120 across 169 interventional studies indexed under Eclampsia.

Browse Eclampsia studies →

Lead sponsor

This is the only study on the registry with Melanie Maykin, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects 18 years of age or older
  • Subjects with intrauterine pregnancy at or beyond 20 weeks of gestation
  • Subjects with a diagnosis of hypertensive disorder in pregnancy
  • Subjects with persistent (on repeat BP check 15 min apart) severe range blood pressure recordings (systolic BP greater than or equal to 160 or diastolic greater than or equal to BP 110) with wide pulse pressure (>60 mmHg)
  • Subject able to provide informed consent

Exclusion criteria

Exclusion Criteria:

  • Subjects less than 18 years of age
  • Subjects with intrauterine pregnancy less than 20 weeks of gestation
  • Subjects with known fetal anomaly
  • Subjects with hypokalemia (K \<3.0 milliequivalent per liter) on admission
  • Subjects with anuria (\<50 milliliters urine in 24 hours) or renal failure
  • Subjects previously taking diuretics or potassium supplements for any reason
  • Subjects with a known allergy/adverse reaction to furosemide
  • Subjects who are unable to understand and/or sign the informed consent
  • Subjects who are in active labor defined as 6 centimeters of cervical dilation or more
  • Subjects who have an epidural (neuraxial anesthesia) in place
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Furosemide

    When patient meets inclusion criteria and is randomized to treatment drug, she receives 40mg /4 milliliters (mL) IV furosemide in addition to usual antihypertensive.

    Drug: Furosemide

  • Placebo comparator
    Placebo

    When patient meets inclusion criteria and is randomized to placebo, she receives one dose of 4mL normal saline in addition to usual antihypertensive.

    Other: Placebo

Interventions

  • DrugFurosemide

    Furosemide, a loop diuretic

  • OtherPlacebo

    Normal saline

06

What researchers measure

Primary outcomes

  1. Mean Systolic Blood Pressure During Hour After Study Drug

    Mean systolic blood pressure during hour after study drug administration.

    Time frame: 0 minutes to 60 minutes post-dose

Secondary outcomes

  1. Mean Diastolic Blood Pressure During Hour After Study Drug

    Mean diastolic blood pressure during the 1-hour period after drug administration.

    Time frame: 0 minutes to 60 minutes post-dose

  2. Change From Qualifying Systolic Blood Pressure

    Change from qualifying systolic blood pressure (qualifying SBP-mean SBP during hour after intervention) where qualifying systolic blood pressure refers to a severe range SBP (\>=160 millimeters of mercury (mmHg)) for at least 15 minutes.

    Time frame: 0 minutes to 1 hour post-dose

  3. Change From Qualifying Diastolic Blood Pressure

    Change from qualifying diastolic blood pressure (qualifying DBP-mean DBP during hour after intervention) where qualifying diastolic blood pressure refers to a severe range DBP (\>=110 millimeters of mercury (mmHg)) for at least 15 minutes.

    Time frame: 0 minutes to 1 hour post-dose

  4. Pulse Pressure at 2 Hours After Study Drug.

    Pulse pressure at 2 hours after study drug.

    Time frame: 2 hours post-dose

  5. Systolic Blood Pressure at 2 Hours After Study Drug

    Systolic blood pressure at 2 hours after study drug

    Time frame: 2 hours post-dose

  6. Diastolic Blood Pressure at 2 Hours After Study Drug

    Diastolic blood pressure at 2 hours after study drug

    Time frame: 2 hours post-dose

Other outcomes

  1. Gestational Age at Delivery

    Gestational age in weeks and days at the time of birth

    Time frame: at the time of birth

  2. Time From Admission to Delivery

    Time in days and hours from admission to birth

    Time frame: at the time of delivery

  3. Time From Treatment to Delivery

    Time in days and hours from treatment to birth

    Time frame: at the time of delivery

  4. Induction of Labor

    Number of women who required induction of labor

    Time frame: at the time of induction of labor

  5. Mode of Delivery

    Type of delivery

    Time frame: at time of delivery

  6. Eclampsia

    Number of women who developed seizure

    Time frame: at time of hospital discharge

  7. Low Apgar Scores of Neonate (Apgar Score <7 at 5 Min)

    Neonatal clinical assessment (Apgar is not an abbreviated term). Minimum value 0; maximum value 9; Tool is used for assessment and not an accurate prognostic tool to predict outcomes.

    Time frame: at 5 minutes after delivery

  8. Newborns Admitted to Intensive Care Nursery

    Neonatal Intensive Care Unit admission

    Time frame: assessed from time of delivery until discharge since neonates can be admitted to the NICU at any time during this interval if issues arise.

  9. Time to Achieve First Non-severe BP (m)

    Time to achieve first non-severe BP (m)

    Time frame: Assessed from time of severe range blood pressure to time at resolution of severe range blood pressure. Reported at time of resolution of severe range blood pressure.

  10. Number of Participants Who Required Additional Antihypertensive Agents in an Hour After Allocation

    Were any additional antihypertensive agents in hour after allocation

    Time frame: Assessed from 0 minutes to 1 hour post-dose, 1-hour post-dose reported

  11. Latency Until Next First-line Antepartum Antihypertensive Agents

    time until next first-line antepartum antihypertensive agent given

    Time frame: 0 minutes to delivery of baby (72 hours post-dose)

  12. Discharged Without Delivery

    proportion of participants who were discharged prior to delivery of the baby

    Time frame: at time of hospital discharge

  13. Length of Stay

    length of stay

    Time frame: at time of hospital discharge

  14. Birthweight

    weight of baby at birth

    Time frame: at time of birth

07

Results

Posted Apr 18, 2024

Participant flow

Participant flow — Overall Study
MilestoneFurosemidePlacebo
Started3332
Completed3332
Not completed00

Outcome measures

PrimaryMean Systolic Blood Pressure During Hour After Study Drug

Mean systolic blood pressure during hour after study drug administration.

Time frame:
0 minutes to 60 minutes post-dose
Reported as:
Mean · mmHg
Mean Systolic Blood Pressure During Hour After Study Drug
mmHgFurosemidePlacebo
Mean Systolic Blood Pressure During Hour After Study Drug147 ± 14.8152 ± 13.8
SecondaryMean Diastolic Blood Pressure During Hour After Study Drug

Mean diastolic blood pressure during the 1-hour period after drug administration.

Time frame:
0 minutes to 60 minutes post-dose
Reported as:
Mean · mmHg
Mean Diastolic Blood Pressure During Hour After Study Drug
mmHgFurosemidePlacebo
Mean Diastolic Blood Pressure During Hour After Study Drug88 ± 10.887 ± 9.3
SecondaryChange From Qualifying Systolic Blood Pressure

Change from qualifying systolic blood pressure (qualifying SBP-mean SBP during hour after intervention) where qualifying systolic blood pressure refers to a severe range SBP (\>=160 millimeters of mercury (mmHg)) for at least 15 minutes.

Time frame:
0 minutes to 1 hour post-dose
Reported as:
Mean · mmHg
Change From Qualifying Systolic Blood Pressure
mmHgFurosemidePlacebo
Change From Qualifying Systolic Blood Pressure-26 ± 13.9-24 ± 15.5
SecondaryChange From Qualifying Diastolic Blood Pressure

Change from qualifying diastolic blood pressure (qualifying DBP-mean DBP during hour after intervention) where qualifying diastolic blood pressure refers to a severe range DBP (\>=110 millimeters of mercury (mmHg)) for at least 15 minutes.

Time frame:
0 minutes to 1 hour post-dose
Reported as:
Mean · mmHg
Change From Qualifying Diastolic Blood Pressure
mmHgFurosemidePlacebo
Change From Qualifying Diastolic Blood Pressure-12 ± 7.6-11 ± 8.9
SecondaryPulse Pressure at 2 Hours After Study Drug.

Pulse pressure at 2 hours after study drug.

Time frame:
2 hours post-dose
Reported as:
Mean · mmHg
Pulse Pressure at 2 Hours After Study Drug.
mmHgFurosemidePlacebo
Pulse Pressure at 2 Hours After Study Drug.55 ± 12.567 ± 15.1
SecondarySystolic Blood Pressure at 2 Hours After Study Drug

Systolic blood pressure at 2 hours after study drug

Time frame:
2 hours post-dose
Reported as:
Mean · mmHg
Systolic Blood Pressure at 2 Hours After Study Drug
mmHgFurosemidePlacebo
Systolic Blood Pressure at 2 Hours After Study Drug139 ± 18.5154 ± 18.4
SecondaryDiastolic Blood Pressure at 2 Hours After Study Drug

Diastolic blood pressure at 2 hours after study drug

Time frame:
2 hours post-dose
Reported as:
Mean · mmHg
Diastolic Blood Pressure at 2 Hours After Study Drug
mmHgFurosemidePlacebo
Diastolic Blood Pressure at 2 Hours After Study Drug84 ± 12.587 ± 10.5
Other pre-specifiedGestational Age at Delivery

Gestational age in weeks and days at the time of birth

Time frame:
at the time of birth
Reported as:
Mean · weeks
Gestational Age at Delivery
weeksFurosemidePlacebo
Gestational Age at Delivery34.1 ± 2.934 ± 3.1
Other pre-specifiedTime From Admission to Delivery

Time in days and hours from admission to birth

Time frame:
at the time of delivery
Reported as:
Median · days
Time From Admission to Delivery
daysFurosemidePlacebo
Time From Admission to Delivery2.3 (1.1 to 14.6)3.7 (1.1 to 11.2)
Other pre-specifiedTime From Treatment to Delivery

Time in days and hours from treatment to birth

Time frame:
at the time of delivery
Reported as:
Median · days
Time From Treatment to Delivery
daysFurosemidePlacebo
Time From Treatment to Delivery2.1 (.8 to 10.9)1.8 (.7 to 6.5)
Other pre-specifiedInduction of Labor

Number of women who required induction of labor

Time frame:
at the time of induction of labor
Reported as:
Count of participants · Participants
Induction of Labor
ParticipantsFurosemidePlacebo
Induction of Labor74
Other pre-specifiedMode of Delivery

Type of delivery

Time frame:
at time of delivery
Reported as:
Count of participants · Participants
Mode of Delivery
ParticipantsFurosemidePlacebo
spontaneous vaginal delivery98
operative vaginal delivery02
Cesarean section2422
Other pre-specifiedEclampsia

Number of women who developed seizure

Time frame:
at time of hospital discharge
Reported as:
Count of participants · Participants
Eclampsia
ParticipantsFurosemidePlacebo
Eclampsia00
Other pre-specifiedLow Apgar Scores of Neonate (Apgar Score <7 at 5 Min)

Neonatal clinical assessment (Apgar is not an abbreviated term). Minimum value 0; maximum value 9; Tool is used for assessment and not an accurate prognostic tool to predict outcomes.

Time frame:
at 5 minutes after delivery
Reported as:
Number · neonates
Low Apgar Scores of Neonate (Apgar Score <7 at 5 Min)
neonatesFurosemidePlacebo
Low Apgar Scores of Neonate (Apgar Score <7 at 5 Min)33
Other pre-specifiedNewborns Admitted to Intensive Care Nursery

Neonatal Intensive Care Unit admission

Time frame:
assessed from time of delivery until discharge since neonates can be admitted to the NICU at any time during this interval if issues arise.
Reported as:
Number · neonates
Newborns Admitted to Intensive Care Nursery
neonatesFurosemidePlacebo
Newborns Admitted to Intensive Care Nursery2425
Other pre-specifiedTime to Achieve First Non-severe BP (m)

Time to achieve first non-severe BP (m)

Time frame:
Assessed from time of severe range blood pressure to time at resolution of severe range blood pressure. Reported at time of resolution of severe range blood pressure.
Reported as:
Median · minutes
Time to Achieve First Non-severe BP (m)
minutesFurosemidePlacebo
Time to Achieve First Non-severe BP (m)44 (23 to 75)46 (30 to 76)
Other pre-specifiedNumber of Participants Who Required Additional Antihypertensive Agents in an Hour After Allocation

Were any additional antihypertensive agents in hour after allocation

Time frame:
Assessed from 0 minutes to 1 hour post-dose, 1-hour post-dose reported
Reported as:
Count of participants · Participants
Number of Participants Who Required Additional Antihypertensive Agents in an Hour After Allocation
ParticipantsFurosemidePlacebo
Number of Participants Who Required Additional Antihypertensive Agents in an Hour After Allocation97
Other pre-specifiedLatency Until Next First-line Antepartum Antihypertensive Agents

time until next first-line antepartum antihypertensive agent given

Time frame:
0 minutes to delivery of baby (72 hours post-dose)
Reported as:
Median · hours
Latency Until Next First-line Antepartum Antihypertensive Agents
hoursFurosemidePlacebo
Latency Until Next First-line Antepartum Antihypertensive Agents10.8 (.8 to 31.1)3.2 (.4 to 25.9)
Other pre-specifiedDischarged Without Delivery

proportion of participants who were discharged prior to delivery of the baby

Time frame:
at time of hospital discharge
Reported as:
Count of participants · Participants
Discharged Without Delivery
ParticipantsFurosemidePlacebo
Discharged Without Delivery63
Other pre-specifiedLength of Stay

length of stay

Time frame:
at time of hospital discharge
Reported as:
Median · days
Length of Stay
daysFurosemidePlacebo
Length of Stay6.1 (4.3 to 12.5)7.3 (4.1 to 7.3)
Other pre-specifiedBirthweight

weight of baby at birth

Time frame:
at time of birth
Reported as:
Mean · grams
Birthweight
gramsFurosemidePlacebo
Birthweight1921 ± 534.72070 ± 796.4

Adverse events

Collected over 1 year and 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Furosemide0/33 (0%)0/33 (0%)0/33 (0%)
Placebo0/32 (0%)0/32 (0%)0/32 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)FurosemidePlaceboTotal
<=18 years000
Between 18 and 65 years333265
>=65 years000
Sex/Gender, Customized
Sex/Gender, Customized(Participants)FurosemidePlaceboTotal
Sex — Female333265
Sex — Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)FurosemidePlaceboTotal
Race/Ethnicity — Asian7613
Race/Ethnicity — Filipino161228
Race/Ethnicity — Native Hawaiian347
Race/Ethnicity — Micronesian145
Race/Ethnicity — White516
Race/Ethnicity — All others156
obese
obese(Participants)FurosemidePlaceboTotal
Count of participants141832
insurance
insurance(Participants)FurosemidePlaceboTotal
Commercial241842
Public91423
nulliparous
nulliparous(Participants)FurosemidePlaceboTotal
Count of participants181432
twin pregnancy
twin pregnancy(Participants)FurosemidePlaceboTotal
Count of participants224
hypertension subtype
hypertension subtype(Participants)FurosemidePlaceboTotal
new-onset141832
pre-existing191433
08

Study locations

1 site
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
09

References and documents

Publications

  • Grindheim G, Estensen ME, Langesaeter E, Rosseland LA, Toska K. Changes in blood pressure during healthy pregnancy: a longitudinal cohort study. J Hypertens. 2012 Feb;30(2):342-50. doi: 10.1097/HJH.0b013e32834f0b1c. PubMed 22179091 ↗
  • Phillips JK, Janowiak M, Badger GJ, Bernstein IM. Evidence for distinct preterm and term phenotypes of preeclampsia. J Matern Fetal Neonatal Med. 2010 Jul;23(7):622-6. doi: 10.3109/14767050903258746. PubMed 20482241 ↗
  • Easterling TR, Benedetti TJ, Schmucker BC, Millard SP. Maternal hemodynamics in normal and preeclamptic pregnancies: a longitudinal study. Obstet Gynecol. 1990 Dec;76(6):1061-9. PubMed 2234714 ↗
  • ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018. PubMed 30575675 ↗
  • https://www.uptodate.com/contents/furosemide-drug information?search=furosemide&source=panel_search_result&selectedTitle=1~148&usage_type=panel&kp_tab=drug_general&display_rank=1
  • Tamas P, Hantosi E, Farkas B, Ifi Z, Betlehem J, Bodis J. Preliminary study of the effects of furosemide on blood pressure during late-onset pre-eclampsia in patients with high cardiac output. Int J Gynaecol Obstet. 2017 Jan;136(1):87-90. doi: 10.1002/ijgo.12019. Epub 2016 Nov 3. PubMed 28099709 ↗
  • Ascarelli MH, Johnson V, McCreary H, Cushman J, May WL, Martin JN Jr. Postpartum preeclampsia management with furosemide: a randomized clinical trial. Obstet Gynecol. 2005 Jan;105(1):29-33. doi: 10.1097/01.AOG.0000148270.53433.66. PubMed 15625138 ↗
  • Duley L, Meher S, Jones L. Drugs for treatment of very high blood pressure during pregnancy. Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD001449. doi: 10.1002/14651858.CD001449.pub3. PubMed 23900968 ↗
  • Committee on Obstetric Practice. Committee Opinion No. 692: Emergent Therapy for Acute-Onset, Severe Hypertension During Pregnancy and the Postpartum Period. Obstet Gynecol. 2017 Apr;129(4):e90-e95. doi: 10.1097/AOG.0000000000002019. PubMed 28333820 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 21, 2020
  • Informed consent form · Oct 2, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Will individual participant data be available (including data dictionaries)? Individual participant data will be made available. What data in particular will be shared? Individual participant data that underlie the results reported any future manuscript, after deidentification (text, tables, figures, and appendices). What other documents will be available? There are no plans for additional documents to be made available. When will data be available (start and end dates)? Beginning 9 months and ending 36 months following any publication. With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? To achieve aims in the approved proposal.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04615624
Lead sponsor
Melanie Maykin, MD
Responsible party
Melanie Maykin, MD (Sponsor-Investigator, Hawaii Pacific Health) — Sponsor-investigator
First posted
Nov 4, 2020
Start date
Jan 4, 2021
Primary completion
Apr 22, 2022
Completion
Apr 29, 2022
Results posted
Apr 18, 2024
Last update
Apr 18, 2024

Study contacts

Stacy Tsai, MD
principal investigator · Maternal-Fetal Medicine Faculty

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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