Cervical Bleeding with Cervical Stabilization During IUD Placement: Allis Clamp Versus Single-Tooth Tenaculum

doi:10.21203/rs.3.rs-1434676/v1

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Cervical Bleeding with Cervical Stabilization During IUD Placement: Allis Clamp Versus Single-Tooth Tenaculum

https://doi.org/10.21203/rs.3.rs-1434676/v1

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OBJECTIVE

To evaluate whether the use of an atraumatic Allis clamp will result in less bleeding than the standard single-tooth tenaculum for cervical stabilization during intrauterine device (IUD) placement.

METHODS

A single blinded randomized controlled trial was conducted during insertions of IUDs between March 2017 and March 2018. University of Kentucky Institutional Review Board (IRB 16-1110-P3K) approval was obtained. Physicians were randomized to use either an Allis clamp or a single-tooth tenaculum for cervical stabilization. A post-procedure questionnaire was used to collect outcome measures as well as demographic and obstetric related factors.

RESULTS

Of the ninety-five participants, there was no difference in age, self-identified race/ethnicity, or the evaluated obstetric factors between the groups. Bleeding was present after clamp removal in 3 (6.3%) insertions using an Allis clamp and 26 (55.3%) insertions using a single-tooth tenaculum (RR = 0.113, CI=[0.037, 0.3481], p < 0.0001). There was no difference in IUD insertion success rates between the two clamps. There was no difference in the number of interventions required for hemostasis when bleeding occurred after clamp removal. Pain scores did not differ based on clamp type or age of patient, but were significantly different based on parity (p < 0.001) and IUD type (p < 0.003).

CONCLUSION

The Allis clamp should be used instead of a single-tooth tenaculum for cervical stabilization because of decreased incidence of clamp site bleeding with unchanged insertion success.

The trial was retrospectively registered on 1/11/22 (trial registration number NCT05187078).

Allis clamp

single-tooth tenaculum

cervical stabilization

Intrauterine device

Cervical stabilization is an important aspect of several gynecologic procedures that allows safe access to the intrauterine cavity. Some of these procedures include post-partum IUD insertions, endometrial biopsies, Hysteroscopy, Dilation & Curettage, and Hysterosalpingograms. Historically, the device selected for cervical stabilization most commonly is the single-tooth tenaculum. This is primarily based on manufacturer instruction recommendations for IUD placement [1, 2] and the use of a tenaculum on the cervix to provide traction and to reduce the cervicouterine angle during insertion. Single-tooth tenaculums are traumatic clamps that puncture the cervical epithelium and stroma causing bleeding after clamp removal. The bleeding requires extra time and interventions to ensure hemostasis. The cervical clamp site bleeding ultimately prolongs the IUD insertion procedure, increases the need for extra procedural steps, and thus increases speculum insertion time for the patient.

Intrauterine devices (IUDs) are a highly effective and safe form of long-acting, reversible contraception (LARC). The use of LARCs in the United States has steadily increased since 2002, however, they continue to represent a small percent of the types of contraception utilized. In 2014, only 14% of women utilized a LARC with 12% being IUDs [3, 4]. Common barriers to the use of IUDs include the potential need for multiple clinic appointments, cost, patient comfort, and provider knowledge gaps [5].

No study has directly compared the incidence of cervical clamp site bleeding while using either an Allis clamp or a single-tooth tenaculum for IUD insertion. A similar study compared these two devices; however, patient perceived pain was the primary outcome [6]. Another study compared a vulsellum and single-tooth tenaculum, which found differences in duration of time to control bleeding [7]. The primary objective of this study is to determine if the Allis clamp is an effective clamp for cervical stabilization, while altogether avoiding cervical clamp site bleeding. We also evaluated the number of interventions required for cervical clamp site bleeding to achieve hemostasis within each group.

The University of Kentucky Institutional Review Board (IRB 16-1110-P3K) approved the parallel randomized controlled trial, conducted between March 2017 and March 2018. The study clinicians were employed by the University of Kentucky College of Medicine within the Department of Obstetrics and Gynecology. The study clinicians recruited 95 female patients over the study collection time period, ages 18–50, who presented to ambulatory clinics for an IUD insertion. The study participants completed written informed consent (Fig. 1). The study clinicians obtained a study envelope that contained a color-coded card with instructions to use either a single-tooth tenaculum or an Allis clamp for the IUD insertion. The color-coded cards were placed in the study envelopes via a 1:1 randomization scheme with the allocation sequence being concealed by using sequentially numbered opaque, sealed envelopes in the clinic locations. The study clinicians inserted the IUD per their usual technique except they used the cervical stabilization clamp directed by their study envelope. The study clinicians filled out the post-procedure questionnaire after completing the IUD insertion. The blinded participants also filled out a post-procedure questionnaire that focused on pain scales. Participants’ race was self-identified for clinical registration, including “White” and “Other” groups.

Our primary outcome was cervical clamp site bleeding after clamp removal. Secondary outcomes were IUD insertion success and the number of interventions required for cervical clamp site bleeding hemostasis.

We used IBM SPSS Statistics for Windows to perform X² tests to evaluate the association between clamp type and site bleeding as well as IUD type and demographics. We used Fisher tests to evaluate the association between IUD placement success and IUD type when appropriate. The trial was retrospectively enrolled on 1/11/22 with clinicaltrials.gov; trial registration number NCT05187078.

We enrolled 95 patients into the study and 93 participants had IUDs placed successfully. One patient in the Allis clamp group and one patient in the single-tooth tenaculum failed placement. The Allis clamp group had 48 patients and the single-tooth tenaculum group had 47 patients. There were no differences between the groups mean age, self-identified race/ethnicity, or parity status (Table 2). Most of the study participants were Caucasian women (81%) between the ages of 20–29 (45%), multiparous with prior SVD (56%), and most desired levonorgestrel 52mg intrauterine system placement (79%) over other IUD types.

The rate of cervical site bleeding was significantly different between the Allis clamp and single-tooth tenaculum groups (Table 3). Bleeding was seen in 26 (55.3%) patients when a single-tooth tenaculum was used for cervical stabilization, as opposed to only 3 (6.3%) patients in the Allis clamp group (p < 0.0001, RR = 0.113, 95% CI=[0.037, 0.348]). Furthermore, hemostasis was achieved in all Allis clamp group patients within one (66.7%) or two interventions (33.3%). Whereas, 6 patients who had cervical stabilization with the single-tooth tenaculum required additional third (3.8%) and fourth (19.2%) hemostatic interventions (Table 2).

Failure of IUD placement occurred once in both cervical stabilization device groups, indicating no difference in IUD placement success rates, > 97%, for both (p value 1.000). Mean pain scores were not found to be statistically different between the type of cervical stabilization device used (average score of 4 for both, p value 0.415). Pain scores were additionally analyzed based on sub-groups of populations. Mean pain scores were again not found to be statistically significant between different ages < 35yo vs > 35yo (p value 0.681), self-identified race (p value 0.990), if there was cervical bleeding with the device or not (p value 0.508), or the duration of time to hemostasis (p value 0.670). (Fig. 3)

Nevertheless, pain scores were found to be significantly different between patients based on their parity status (p < 0.0001). Regardless of the cervical stabilization device used, the mean pain score for nulliparous women was 6, as opposed to multiparous women with prior spontaneous vaginal delivery (SVD) who had mean pain scores of 3. Pain scores were also found to be significantly different based on the type of IUD placed, especially among nulliparous women (p value < 0.003). (Fig. 4)

The authors find cervical clamp site bleeding frustrating after single-tooth tenaculum use during IUD insertions. The bleeding prolongs the procedure and increases the need of hemostatic interventions. We designed a study to prove that a less traumatic clamp could provide equal procedure success rates while practically eliminating the worry about cervical clamp site bleeding when the clamp is removed. We developed this hypothesis based on the observed shallower penetration depth that an Allis clamp reaches on the cervix and the fact that Allis clamp distributes its force over a larger surface area. Our study found that there is a statistically significant decrease in rate of cervical site bleeding with the use of an Allis clamp versus a single-tooth tenaculum during cervical stabilization. Additionally, clear trends showed a decrease in the number of interventions needed to achieve hemostasis, if bleeding occurs, when an Allis clamp was used.

The cervical stabilization devices were also found to have equal insertion success rates. There was no statistically significant difference in patient pain scores between the two cervical stabilization devices. Multiparous women with a prior spontaneous vaginal delivery did have significantly lower pain scores than nulliparous patients. The pain scores were obtained from the patient after the entire IUD insertion procedure. The pain score results suggest that the clamp choice did not affect the pain experienced by either group. Other patient factors, such as multiparity, and device factors, such as IUD size, contribute more to a patient’s pain.

Strengths of this study include the fact it was a randomized controlled trial with a simple design. Limitations of this study include a lack of subject diversity, lack of IUD choice diversity, and an overall small number of subjects.

This study has implications beyond IUD insertion. Other procedures that require cervical stabilization such as endometrial biopsy, laminaria insertions, dilation and curettage, hysterosalpingograms, insertion of uterine manipulators, and hysteroscopies could also benefit from the use of an Allis clamp over a single-tooth tenaculum. OB/Gyn hospitalists frequently perform procedures that require cervical stabilization for safe intrauterine access, and should strongly consider an Allis clamp for this purpose to decrease cervical bleeding. Many physicians in our institution have already converted to using an Allis clamp for these procedures based on their experience participating in the trial.

Conflicts of interest/Competing interests – The authors of this paper do not have any financial disclaimers to report. There were no financial support or funding for this study

Author Contributions: All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Dr. Kayce Edwards, and Dr. Bryan Rone. The first draft of the manuscript was written by Dr. Brooke Andrews and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Ethics approval - University of Kentucky Institutional Review Board (IRB 16-1110-P3K) approval was obtained

Consent to participate – All patients gave written consent for participation in the study.

Consent for publication - The authors affirm that human research participants provided informed consent for publication.

Availability of data and material - The authors affirm that all data and materials as well as software application support these published claims and comply with field standards.

Code availability - Not applicable

Acknowledgements and Funding: Acknowledgement for the faculty and staff at the University of Kentucky, department of Obstetrics and Gynecology, for advocating and implementing this trial in their practices. This project was not funded by any organization.

Mirena^® [package insert] Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ. Updated 08/229
Paraguard^® [package insert] Cooper Surgical, Inc. Trumbull, CT. Updated 2/2020
Kavanaugh ML, Jerman J, Finer LB. Changes in use of long-acting reversible contraceptive methods among U.S. women, 2009–2012. Obstetrics & Gynecology 2015;126(5):917–927.
Finer LB, Jerman J, Kavanaugh ML, Changes in use of long-acting contraceptive methods in the United States, 2007–2009. Fertility and Sterility 2012;98(4):893–897.
Baron MM, Potter B, Schrager S. A Review of Long-Acting Reversible Contraception Methods and Barriers to Their Use. WMJ 2018;117(4):156‐159.
Johnson, Lee Taylor DO; Johnson, Isaiah Micah MD; Heineck, Robert Jason MD; Lara-Torre, Eduardo MD Allis Compared With Tenaculum for Stabilization of the Cervix During IUD Placement, Obstetrics & Gynecology: May 2015 - Volume 125 - Issue - p 6S-7S
Doty N, MacIsaac L. Effect of an atraumatic vulsellum versus a single-tooth tenaculum on pain perception during intrauterine device insertion: a randomized controlled trial. Contraception 2015;92(6):567-571.

Fig 2.

Demographic information for the patients enrolled in the study and their corresponding p-values between groups using Allis clamps or single-tooth tenaculum

		Allis clamp	Single-tooth Tenaculum	p value
Age (mean, ± SD)		29.42 (±1.06)	29.74 (±1.13)	0.833
Race (n, %)
	Other	7 (14.6%)	11 (23.4%)
	White	41 (85.4%)	36 (76.6%)	0.273
Parity (n, %)
	Multiparous w/ prior SVD	25 (52.1%)	28 (59.6%)
	Multiparous w/o prior SVD	10 (20.8%)	9 (19.1%)
	Nulliparous	13 (27.1%)	10 (21.3%)	0.740
IUD type (n, %)
	Kyleena	3 (6.3%)	3 (6.4%)
	Mirena	39 (81.3%)	36 (76.6%)
	Parguard	5 (10.4%)	4 (8.5%)
	Skyla	1 (2.1%)	4 (8.5%)	0.568

Fig. 3

Analyzes primary and secondary outcomes between Allis clamps and single-tooth tenaculums used for cervical stabilization, including IUD placement success, bleeding, hemostasis interventions, and pain scores (0-10)

		Allis clamp	Single-tooth tenaculum	p value
Placement (N,%)
	Success	47 (97.9%)	46 (97.8%)
	Failure	1 (2.1%)	1 (2.1%)	1.000
Bleeding (N,%)
	present	3 (6.3%)	26 (55.3%)
	absent	45 (93.8%)	21 (44.7%)	<0.0001 RR: 0.113 95% CI=[0.037, 0.348]
Hemostasis interventions (N,%)
	One intervention	2 (66.7%)	14 (53.8%)	1.000
	Two interventions	1 (33.3%)	6 (23.1%)
	Three interventions	0	1 (3.8%)
	Four interventions	0	5 (19.2%)
Pain (mean, ± SE)		4 (±2.2)	4 (±2.1)	0.4154

Fig. 4

Average subjective pain scores reported by patients during intrauterine device placement

		Mean Pain Score out of 10 (± SD)	P value
Device			0.415
	Allis clamp	4 (±2.2)
	Single-tooth tenaculum	4 (±2.1)
Bleeding			0.508
	No	4 (±2.2)
	Yes	4 (±2.0)
IUD type			0.003
	Kyleena	6 (±0.6)
	Mirena	4 (±2.2)
	Paraguard	3 (±1.2)
	Skyla	6 (±1.1)
Parity			<0.001
	Multiparous with prior SVD	3 (±1.7)
	Multiparous without prior SVD	4 (±1.7)
	Nulliparous	6 (±1.7)
Age			0.681
	<35	4 (±2.1)
	>= 35	4 (±2.3)
Time to hemostasis			0.670
	30-60 seconds	5 (±2.3)
	<30 seconds	4 (±2.2)
	>60 seconds	4 (±1.5)

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Reviews received at journal
24 Mar, 2022
Reviewers invited by journal
21 Mar, 2022
Editor invited by journal
20 Mar, 2022
Editor assigned by journal
12 Mar, 2022
First submitted to journal
09 Mar, 2022

You are reading this latest preprint version

Cervical Bleeding with Cervical Stabilization During IUD Placement: Allis Clamp Versus Single-Tooth Tenaculum

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Abstract

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