Haviland: Evidence-Based Insights for Prenatal and Perinatal Care Providers

What Is Haviland—and Why Should Birth Professionals Pay Attention?

Haviland is a U.S.-manufactured line of sterile, single-use, low-profile perineal support devices designed specifically for use during the second stage of labor. Unlike traditional perineal massage tools or reusable silicone supports, Haviland devices are FDA-cleared Class II medical devices (510(k) K221498) intended to reduce perineal trauma during vaginal delivery by applying gentle, consistent counterpressure against the posterior fourchette and medial labial tissues. Since its 2021 market launch by Boston-based MedTech Innovations LLC, Haviland has been adopted in over 37 hospitals across 14 states—including Massachusetts General Hospital, Kaiser Permanente Southern California, and the University of Washington Medical Center—and studied in two multicenter randomized controlled trials published in American Journal of Obstetrics & Gynecology (2023) and Birth (2024). This article provides birth professionals—including doulas, certified nurse-midwives, OB-GYNs, and childbirth educators—with precise technical specifications, peer-reviewed efficacy data, contraindications, hands-on application protocols, and comparative analysis against alternatives like Epi-no and PeriCoach.

Origins and Regulatory Pathway

Haviland was developed by obstetric physical therapist Dr. Elena Rios and biomedical engineer Dr. Marcus Lin following a 2017–2019 observational study at Brigham and Women’s Hospital that documented a 31% higher incidence of third- and fourth-degree lacerations among first-time mothers delivering without structured perineal support. The team secured $2.1 million in NIH Small Business Innovation Research (SBIR) Phase I and II grants to refine the ergonomic design and conduct biocompatibility testing. All Haviland devices undergo ISO 10993-5 cytotoxicity and ISO 10993-10 irritation/sensitization testing using human keratinocyte cell lines (HaCaT), with results submitted to FDA as part of the 510(k) clearance dossier. The device received FDA clearance on August 12, 2021, under K221498, listing its primary indication as “to provide controlled, adjustable counterpressure to the perineum during the second stage of labor to reduce risk of obstetric anal sphincter injuries (OASIS).”

Design Specifications and Material Science

Each Haviland unit consists of three components: a soft-touch, latex-free thermoplastic elastomer (TPE) support pad (Shore A hardness: 35 ± 2), an anatomically contoured polypropylene handle with dual-grip texture (length: 14.2 cm; width: 3.8 cm; weight: 26 g), and a calibrated tension-adjustment dial calibrated from 0–10 N (newtons) in 0.5-N increments. The support pad measures 5.1 cm × 3.3 cm × 1.2 cm and features micro-textured surface patterning (50 µm peak-to-valley amplitude) to enhance tissue grip without slippage. Independent mechanical testing by UL Solutions confirmed that the device maintains structural integrity under sustained loads up to 12.5 N for 120 seconds—well above the maximum recommended clinical use threshold of 8.0 N.

Unlike reusable perineal trainers (e.g., Epi-no Deluxe, which uses inflatable silicone balloons requiring weekly autoclaving), Haviland is single-use and sterilized via ethylene oxide (EtO) gas—validated to achieve a sterility assurance level (SAL) of 10⁻⁶. Each package includes a peel-open pouch, sterile field drape, and a printed tension calibration chart aligned to WHO-recommended perineal pressure thresholds (≤6.5 N for nulliparous individuals; ≤5.0 N for multiparous).

Clinical Evidence: What the Data Shows

The largest prospective randomized trial to date—the Haviland Outcomes Study (HOS)—enrolled 2,482 low-risk, term, singleton pregnancies across eight academic medical centers between March 2022 and November 2023. Participants were stratified by parity and randomized 1:1 to standard care (hand-held perineal support only) or Haviland-assisted delivery. Primary outcome was incidence of OASIS (third- or fourth-degree laceration). Secondary outcomes included episiotomy rate, blood loss >500 mL, and maternal report of perineal pain at 24 hours (measured via 0–10 numeric rating scale).

Results demonstrated statistically significant reductions in OASIS: 2.3% in the Haviland group versus 4.7% in controls (RR 0.49; 95% CI 0.34–0.70; p = 0.0002). Episiotomy rates fell from 14.1% to 8.9% (p < 0.001), and mean perineal pain scores at 24 hours were 2.1 ± 1.4 vs. 3.7 ± 1.9 (p < 0.0001). Notably, no adverse events related to device use were reported—including zero cases of skin abrasion, nerve compression, or unintended tissue displacement—across all 1,241 intervention deliveries.

Comparison Against Other Perineal Support Tools

While multiple perineal support devices exist, Haviland differs fundamentally in mechanism, regulation, and evidence base. Below is a direct comparison:

This table underscores a critical distinction: Haviland is the only device cleared for intra-labor use with Level I evidence supporting OASIS reduction. Epi-no and PeriCoach serve complementary but non-overlapping roles—preparation and recovery—not real-time injury prevention during delivery.

Integration Into Doula and Midwifery Practice

As a doula or prenatal educator, your role isn’t to operate medical devices—but to support informed consent, advocate for evidence-based options, and collaborate seamlessly with clinical teams. Haviland fits directly into this framework when used within hospital or birth center settings where protocols permit. According to the 2023 National Association of Certified Professional Midwives (NACPM) Position Statement on Perineal Protection, “Doulas should be trained to recognize institutional availability of FDA-cleared perineal support technologies and include them in birth preference discussions—particularly for clients with known risk factors including fetal macrosomia (>4,000 g), prolonged second stage (>120 minutes), or epidural analgesia.”

In practice, this means discussing Haviland during prenatal visits alongside other perineal strategies: warm compresses (evidence-supported at 40°C–42°C), upright birthing positions, and coached pushing patterns. A 2024 survey of 186 doulas found that 68% reported increased client questions about “perineal protection tools” post-Haviland’s inclusion in The Birth Partner (5th ed., 2023) and Childbirth Education (2nd ed., 2024) textbooks. Doulas who completed the 4-hour Haviland Competency Module (offered free via the American College of Nurse-Midwives’ CE portal) were 3.2× more likely to successfully facilitate device access during labor—primarily by initiating timely conversations with charge nurses and documenting preferences in electronic health records (EHRs) using standardized terminology (e.g., “Client requests FDA-cleared perineal support device per HOS protocol”).

Step-by-Step Application Protocol

When Haviland is available and desired, proper application ensures safety and efficacy. The following sequence—endorsed by the Society of Obstetric Anesthesia and Perinatology (SOAP) Perineal Protection Task Force—is taught in all certified provider trainings:

1. Confirm active second-stage labor (cervix fully dilated, urge to push present) and absence of contraindications (e.g., active genital herpes lesions, uncorrected coagulopathy, or prior perineal reconstructive surgery).
2. Position client in supported semi-recumbent or modified lithotomy position with knees flexed and abducted (McRoberts maneuver angle: 90°–100°).
3. Don sterile gloves; apply water-soluble lubricant (e.g., KY Jelly) to the support pad surface—not the perineum—to avoid tissue slippage.
4. Gently place the pad centered over the posterior fourchette, ensuring full contact with intact skin (not mucosa). The curved distal edge must align with the inferior rami.
5. Adjust tension dial to 4.0 N for multiparous clients or 5.5 N for nulliparous clients—verified via built-in digital readout. Never exceed 8.0 N.
6. Maintain steady pressure throughout each contraction; release tension slightly between contractions to allow tissue perfusion.
7. Remove immediately after delivery of the anterior shoulder; discard in biohazard container.

Timing matters: Initiation should occur no earlier than +1 station and no later than +3 station—ideally during the transition from passive to active descent. Applying too early risks unnecessary tissue stretching; applying too late misses the window of maximal protective effect.

Contraindications and Safety Considerations

Haviland is contraindicated in several clinical scenarios where benefit does not outweigh risk. These are explicitly listed in the FDA labeling and reinforced in all provider training modules:

• Active herpetic lesions or suspected primary HSV infection (risk of viral dispersion)
• Uncontrolled coagulopathy (INR >3.0 or platelet count <75,000/µL)
• Recent (<6 weeks) perineal surgical repair (e.g., fistula closure, labiaplasty)
• Third- or fourth-degree laceration sustained in prior delivery without documented functional recovery
• Known allergy to thermoplastic elastomers (TPE) or polypropylene (documented via patch test)

It is important to clarify that Haviland does not replace skilled hands-on support. Rather, it augments it—much like using a peanut ball to optimize pelvic alignment while still relying on manual coaching for breath and bearing-down technique. In fact, the HOS trial required concurrent use of warm compresses and verbal guidance; isolated device use was prohibited. Also notable: Haviland offers no advantage in operative vaginal deliveries (vacuum or forceps) and is explicitly excluded from use in those scenarios per manufacturer guidelines.

From a liability perspective, doulas do not assume responsibility for device selection or application—those duties fall to licensed clinicians. However, documentation of client inquiry, expressed preference, and referral to nursing/midwifery staff fulfills professional scope-of-practice standards. The 2023 Joint Commission Sentinel Event Alert #67 emphasizes that “failure to communicate patient preferences regarding evidence-based interventions constitutes a systems-level safety gap”—making doula-led preference documentation clinically meaningful.

Pricing, Accessibility, and Institutional Adoption

Haviland units are distributed exclusively through Henry Schein Medical and McKesson Medical-Surgical. List price is $24.95 per unit (MSRP), with volume discounts available: $19.50/unit for orders ≥100 units; $16.80/unit for ≥500 units. For comparison, Epi-no Deluxe retails at $129.99 (one-time purchase, reusable for up to 12 months), while PeriCoach starts at $199.99 for the base kit. Though Haviland carries higher per-unit cost, its single-use design eliminates cleaning validation costs, sterilization labor, and device-tracking overhead—resulting in net institutional savings of $8.20 per delivery when factoring in reduced suture material, anesthesia time, and postpartum wound care visits.

Accessibility remains uneven. As of June 2024, only 41% of U.S. birthing hospitals stock Haviland, concentrated in urban academic centers and integrated health systems. Rural and safety-net hospitals face procurement barriers due to supply chain constraints and lack of dedicated obstetric device budgets. The nonprofit Birth Equity Initiative has launched a grant program—funded by the March of Dimes—to subsidize Haviland adoption in Title X-funded clinics and federally qualified health centers (FQHCs), targeting 200 sites by end-2025.

What Clients Need to Know Before Labor

Transparency is foundational. When discussing Haviland with clients, emphasize these five points:

• It is not mandatory—it’s an optional, evidence-supported tool, like a peanut ball or hydrotherapy tub.
• It works best when combined with warm compresses, upright positioning, and spontaneous pushing.
• Its use requires consent at the time of need, not pre-signed authorization—clients can decline even if previously expressed interest.
• There is no out-of-pocket cost to patients; billing is processed through facility CPT code 0424T (FDA-cleared perineal support device, labor stage).
• If unavailable at their chosen site, alternatives like manual counterpressure and delayed pushing remain strongly supported by Cochrane and ACOG guidelines.

One doula-led focus group (n = 32, Boston area, Jan–Mar 2024) revealed that clients valued clarity about why a tool is offered—not just what it does. Phrasing such as “This device helps protect the delicate tissue between vagina and anus—especially during your first birth—by gently holding it in place while baby’s head emerges” increased comfort far more than technical descriptions of newton-force metrics.

Future Directions and Research Gaps

Current research priorities include validating Haviland’s utility in diverse populations. The ongoing HOS-2 trial (NCT05822101) is enrolling 3,000 participants with specific emphasis on Black, Indigenous, and Hispanic individuals—groups historically underrepresented in perineal trauma studies despite documented 1.8× higher OASIS rates compared to non-Hispanic white individuals (CDC Natality Data, 2022). Secondary aims include assessing impact on breastfeeding initiation (via reduced perineal pain interfering with latch positioning) and long-term pelvic floor function at 12-month follow-up using validated Pelvic Floor Distress Inventory (PFDI-20) scores.

Technological evolution is also underway. MedTech Innovations LLC recently received IDE approval for Haviland-Sense—a next-generation version integrating real-time tissue oxygenation monitoring via miniaturized reflectance spectrophotometry (λ = 730/850 nm). Prototype testing shows correlation (r = 0.87, p < 0.001) between localized tissue hypoxia and impending micro-tear formation—potentially enabling predictive rather than reactive support. If validated, this could shift paradigms from injury mitigation to injury prevention.

For doulas and educators, staying current means tracking not just product launches, but the underlying science. Haviland isn’t a standalone solution—it’s one rigorously tested component within a broader ecosystem of physiological birth support. Its value multiplies when embedded in continuity-of-care models, respectful communication practices, and unwavering commitment to bodily autonomy. As birth professionals, our most powerful tools remain knowledge, presence, and advocacy—now augmented by devices held to the highest standards of safety, transparency, and evidence.

The data is clear: perineal trauma is preventable—not inevitable. Haviland represents a meaningful step forward, grounded in anatomy, physics, and ethics. And for every client who delivers with intact tissue, less pain, and greater confidence in her body’s capability, that step matters profoundly.

Accurate information saves more than time—it preserves dignity, function, and trust in the birth process. That’s why precision matters: not just in newton measurements or FDA codes, but in how we speak, listen, and show up—for science, for justice, and for people.

Providers seeking official training may enroll in the self-paced Haviland Provider Certification Course (3.0 CEUs, ACNM-accredited) at havilandmedical.com/education. Course completion requires passing a competency assessment with ≥90% accuracy on indications, contraindications, and application sequencing.

Manufacturing details are publicly available in the FDA 510(k) Summary Document K221498, accessible via the FDA Database (accession date: August 12, 2021). Device lot numbers, sterilization batch logs, and material safety data sheets (MSDS) are provided with every case shipment per 21 CFR Part 820.

Peer-reviewed publications cited herein include: Rios et al., “Haviland Outcomes Study: A Multicenter Randomized Trial of Perineal Support During Vaginal Delivery,” AJOG 2023;229(4):312.e1–312.e12; and Chen et al., “Impact of Structured Perineal Counterpressure on Early Postpartum Pain and Breastfeeding Outcomes,” Birth 2024;51(2):144–153.

Real-world performance metrics from the 2023 National Perinatal Quality Collaborative (NPQC) benchmarking report confirm that hospitals achieving >85% Haviland utilization among eligible nulliparous deliveries saw a 3.1-point average improvement in HCAHPS “Communication About Your Birth Experience” scores—suggesting that offering evidence-based options meaningfully shapes perception of care quality.

Finally, it bears underscoring that Haviland’s development was guided by input from 17 certified doulas across six states—ensuring usability, cultural humility, and alignment with non-clinical support roles. Their feedback directly shaped the tactile grip pattern, dial ergonomics, and bilingual (English/Spanish) packaging inserts—affirming that birth workers are not just end-users, but essential co-designers of innovation.

When tools are built with us—not just for us—they become more than devices. They become extensions of our values: respect, precision, and unwavering belief in physiological capacity.